Quality Engineer II (Onsite) - Olympus Corporation of the Americas
Brooklyn Park, MN
About the Job
Working Location: MINNESOTA, BROOKLYN PARK
Workplace Flexibility: Onsite
_For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ __
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
Job Description
Provide Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company. Represents Quality as a team member to support new product development product manufacturing transfers procurement on-going manufacturing returns and servicing of products produced.
Job Duties
+ Cross Functional Team member to support new product development product manufacturing transfers procurement on-going manufacturing and servicing processes representing Quality Engineering discipline and completes assigned Quality Engineering tasks to schedule. Promotes awareness of Quality and Regulatory requirements.
+ Leads or participates in the development of process and procedure development changes.
+ Applies statistical methodology to evaluate current processes and process changes. Develops new approaches to solve problems identified as part of the team. Assists in the implementation compliance and maintenance of standards (e.g. FDA ISO 13485) and OSTA Quality policies and procedures. Trains location personnel on all aspects of the Quality System and regulatory standards. Applies the requirements of the Quality System to processes products or services for the location. Supports the manufacturing line to address quality issues and resolution. Provides support to metrology component inspection methods and preventive maintenance programs. Supports validation and verification strategy for new and existing products and processes as assigned. Leads the development and maintenance of product Master Validation Plans. Participates in the CAPA process as required as a CAPA Lead or CAPA project team member. As requested by Market Quality function investigates escalated product complaints related to manufacturing issues to root cause to ensure timely customer response and correction. Monitors product and process performance metrics and acts upon trends (positive or negative). Leads MRB as a team member to ensure proper disposition of non conformances. Authors collaborates and approves Quality System documentation including changes orders DHF DMR OHR labels and labelling. Supports site regulatory inspections internal audits or customer audits as requested Interfaces with SQE function to resolve Quality issues. Develops and drives measurable Quality improvements relating to products processes and services.
+ All other essential duties as assigned.
Job Qualifications
Required:
+ A minimum of a bachelor's degree (B.S.) in science/engineering discipline or equivalent industry experience.
+ Minimum of 3 years of related experience preferable in the medical device industry related to process/quality engineering.
Preferred:
+ Knowledge of basic mechanical testing and material properties.
+ Knowledge of metrology.
+ Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD93/42 ISO 13485-2016 and Canadian Medical Device requirements.
+ ASQ certifications in one or more of the following areas is preferred but not required: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
+ Working knowledge of Problem-Solving Tools (i.e. Process Mapping Histograms FMEA Risk Assessment Cause & Effect Diagrams POCA Pareto Analysis etc.).
+ Working knowledge of Quality Tools (i.e. Quality Planning Quality Costs and Assessment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles and AQL TQM Lean Six Sigma etc.)
+ Strong verbal and written communication skills in a cross functional team environment.
+ Demonstrated ability to generate technical reports and the ability to make presentations to middle and upper management.
+ Proficient in the use of Information Technology and applications.
Why join Olympus?
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
Equitable Offerings you can count on:
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities:**
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)
Workplace Flexibility: Onsite
_For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ __
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
Job Description
Provide Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company. Represents Quality as a team member to support new product development product manufacturing transfers procurement on-going manufacturing returns and servicing of products produced.
Job Duties
+ Cross Functional Team member to support new product development product manufacturing transfers procurement on-going manufacturing and servicing processes representing Quality Engineering discipline and completes assigned Quality Engineering tasks to schedule. Promotes awareness of Quality and Regulatory requirements.
+ Leads or participates in the development of process and procedure development changes.
+ Applies statistical methodology to evaluate current processes and process changes. Develops new approaches to solve problems identified as part of the team. Assists in the implementation compliance and maintenance of standards (e.g. FDA ISO 13485) and OSTA Quality policies and procedures. Trains location personnel on all aspects of the Quality System and regulatory standards. Applies the requirements of the Quality System to processes products or services for the location. Supports the manufacturing line to address quality issues and resolution. Provides support to metrology component inspection methods and preventive maintenance programs. Supports validation and verification strategy for new and existing products and processes as assigned. Leads the development and maintenance of product Master Validation Plans. Participates in the CAPA process as required as a CAPA Lead or CAPA project team member. As requested by Market Quality function investigates escalated product complaints related to manufacturing issues to root cause to ensure timely customer response and correction. Monitors product and process performance metrics and acts upon trends (positive or negative). Leads MRB as a team member to ensure proper disposition of non conformances. Authors collaborates and approves Quality System documentation including changes orders DHF DMR OHR labels and labelling. Supports site regulatory inspections internal audits or customer audits as requested Interfaces with SQE function to resolve Quality issues. Develops and drives measurable Quality improvements relating to products processes and services.
+ All other essential duties as assigned.
Job Qualifications
Required:
+ A minimum of a bachelor's degree (B.S.) in science/engineering discipline or equivalent industry experience.
+ Minimum of 3 years of related experience preferable in the medical device industry related to process/quality engineering.
Preferred:
+ Knowledge of basic mechanical testing and material properties.
+ Knowledge of metrology.
+ Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD93/42 ISO 13485-2016 and Canadian Medical Device requirements.
+ ASQ certifications in one or more of the following areas is preferred but not required: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
+ Working knowledge of Problem-Solving Tools (i.e. Process Mapping Histograms FMEA Risk Assessment Cause & Effect Diagrams POCA Pareto Analysis etc.).
+ Working knowledge of Quality Tools (i.e. Quality Planning Quality Costs and Assessment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles and AQL TQM Lean Six Sigma etc.)
+ Strong verbal and written communication skills in a cross functional team environment.
+ Demonstrated ability to generate technical reports and the ability to make presentations to middle and upper management.
+ Proficient in the use of Information Technology and applications.
Why join Olympus?
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
Equitable Offerings you can count on:
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities:**
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)
Source : Olympus Corporation of the Americas
