Engineer, Principal Quality - Remote - Olympus Corporation of the Americas
Center Valley, PA
About the Job
Working Location: NATIONWIDE
Workplace Flexibility: Field
_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
Support the development, writing and completion of Health Hazard Assessment (HHAs) across Olympus globally with focus on writing data driven, evidence based HHAs with robust issue analysis, and justified conclusions and summaries. Works to ensure HHA development and assessments occurs in a timely manner to address safety and compliance areas of our business and to ensure proper documentation are in place. This position will directly lead and/or support continuous improvement and sustaining efforts for the global processes and systems to assure compliance, harmonization, and efficiency.
Job Duties
+ Leads a HHA project team to create, investigate, write and manage a HHA through to completion.
+ Ensure HHA deadlines are achieved. Works to meet key performance indicators.
+ Prepares HHA supporting materials and presents HHA to Field Corrective Action review board. Responds to requests for HHA amendments in a timely manner.
+ Maintain current knowledge of industry best practices and regulatory requirements as well as Olympus operations across the areas of HHAs and Field Actions, complaint handling, adverse event reporting, CAPA and Post Market Surveillance activities in support of HHA development and expert guidance for the HHA teams.
+ Responsible for successful preparation and timely distribution of completed HHAs to the Field Corrective Action (FCA) Review Board for FCA voting.
+ Responsible for working in partnership with Medical Safety, Regulatory, Complaint, CAPA, and Non- Conforming teams to identify, document and escalate, where necessary, situations requiring HHA analysis.
+ Collaborates with global/regional leaders on relevant HHAs and interacts with Legal and Compliance as required.
+ Supports HHA inspections and is key internal HHA inspection leader in support of regulatory inspections.
Job Qualifications
Required:
+ Bachelor’s Degree or equivalent in a technical or science-related field is required.
+ Minimum 8 years’ experience working in finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.
+ Flexible working hours across multiple time zones, due to the Global nature of this role.
Preferred:
+ Knowledge of Risk Management practices, Corrective and Preventative Actions and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971 & 21 CFR 820 is preferred.
+ Ability to influence across multiple sites.
+ Must be self-motivated with a strong sense of urgency to solve issues.
+ Ability to consistently deliver on required activities and meet assigned deadlines.
+ Demonstrated ability to manage and complete multiple projects and assigned objectives.
+ Prior experience leading cross-functional teams.
+ Excellent verbal and written communication skills, including public speaking and facilitation.
+ Excellent interpersonal skills and experience working with different personalities, cultures, and levels of management.
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) .
The anticipated base pay range for this full-time position working at this location is $141,339.00 - $197,875.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)
Workplace Flexibility: Field
_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
Support the development, writing and completion of Health Hazard Assessment (HHAs) across Olympus globally with focus on writing data driven, evidence based HHAs with robust issue analysis, and justified conclusions and summaries. Works to ensure HHA development and assessments occurs in a timely manner to address safety and compliance areas of our business and to ensure proper documentation are in place. This position will directly lead and/or support continuous improvement and sustaining efforts for the global processes and systems to assure compliance, harmonization, and efficiency.
Job Duties
+ Leads a HHA project team to create, investigate, write and manage a HHA through to completion.
+ Ensure HHA deadlines are achieved. Works to meet key performance indicators.
+ Prepares HHA supporting materials and presents HHA to Field Corrective Action review board. Responds to requests for HHA amendments in a timely manner.
+ Maintain current knowledge of industry best practices and regulatory requirements as well as Olympus operations across the areas of HHAs and Field Actions, complaint handling, adverse event reporting, CAPA and Post Market Surveillance activities in support of HHA development and expert guidance for the HHA teams.
+ Responsible for successful preparation and timely distribution of completed HHAs to the Field Corrective Action (FCA) Review Board for FCA voting.
+ Responsible for working in partnership with Medical Safety, Regulatory, Complaint, CAPA, and Non- Conforming teams to identify, document and escalate, where necessary, situations requiring HHA analysis.
+ Collaborates with global/regional leaders on relevant HHAs and interacts with Legal and Compliance as required.
+ Supports HHA inspections and is key internal HHA inspection leader in support of regulatory inspections.
Job Qualifications
Required:
+ Bachelor’s Degree or equivalent in a technical or science-related field is required.
+ Minimum 8 years’ experience working in finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.
+ Flexible working hours across multiple time zones, due to the Global nature of this role.
Preferred:
+ Knowledge of Risk Management practices, Corrective and Preventative Actions and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971 & 21 CFR 820 is preferred.
+ Ability to influence across multiple sites.
+ Must be self-motivated with a strong sense of urgency to solve issues.
+ Ability to consistently deliver on required activities and meet assigned deadlines.
+ Demonstrated ability to manage and complete multiple projects and assigned objectives.
+ Prior experience leading cross-functional teams.
+ Excellent verbal and written communication skills, including public speaking and facilitation.
+ Excellent interpersonal skills and experience working with different personalities, cultures, and levels of management.
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) .
The anticipated base pay range for this full-time position working at this location is $141,339.00 - $197,875.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)
Source : Olympus Corporation of the Americas
