Principal Quality Engineer, Post Market Surveillance - 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
In this role, the Principal Quality Engineer will report to the Director of Post Market Surveillance and will lead the execution of post market surveillance projects and improvement programs across the global regions (Japan, EMEA, US etc.). This engineer will also support a global post market surveillance Community of Practice in identifying and implementing best practices.
Job Duties
+ Contribute to the development and maintenance of global post market surveillance procedures.
+ Supports, plans, and executes initiatives that support the Post Market Surveillance Community of Practice for Olympus globally.
+ Leads project workstreams and post market surveillance improvement programs across the global regions.
+ Prepare, conduct, and support routine meetings to ensure accountability and milestone achievements with global teams. Sets prioritization of activities and follow up on actions.
+ Actively seeks collaboration and builds relationships with internal customers to improve overall outcomes that ensure the safety of products and patients.
+ Proactively identify and assess areas of improvements or risks and escalates issues in a timely manner.
+ Support internal and external audits as a subject matter expert.
+ Other essential duties as directed.
Job Requirements
Required:
+ Bachelor of Science degree in engineering or technical discipline.
+ Minimum of 8 years related experience, preferably in the medical device industry related to operations/design/quality engineering.
+ Experience in Post Market Surveillance, including leading or execution of Post Market Surveillance Plans and Periodic Safety Update Reports
+ Knowledge of EU 2017/745 (EU MDR), FDA QSR, ISO 13485 and other applicable industry standards
+ Travel up to 10% of the time domestically or internationally, availability to take evening and early morning teleconferences
Preferred:
+ Proven planning and organizational skills with background and experience in project management principles, practices, techniques, and tools
+ Strong analytical skills and the ability to operate effectively in a team environment
+ Ability to analyze complex problems, interpret operational needs, and develop integrated, creative solutions
+ Must be able to work independently, self-motivated, a sense of ownership with a strong sense of urgency to drive for results
+ Responds well under pressure and manages stress
+ Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance
+ Ability to gain cooperation and commitment from people through influence
+ Excellent verbal and written communication skills and comfortable presenting to small and large groups
+ Expert in Excel, Power Point, Visio, and Word
+ Experience in working with global teams
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 $101,523.00 - $142,132.00 / 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
In this role, the Principal Quality Engineer will report to the Director of Post Market Surveillance and will lead the execution of post market surveillance projects and improvement programs across the global regions (Japan, EMEA, US etc.). This engineer will also support a global post market surveillance Community of Practice in identifying and implementing best practices.
Job Duties
+ Contribute to the development and maintenance of global post market surveillance procedures.
+ Supports, plans, and executes initiatives that support the Post Market Surveillance Community of Practice for Olympus globally.
+ Leads project workstreams and post market surveillance improvement programs across the global regions.
+ Prepare, conduct, and support routine meetings to ensure accountability and milestone achievements with global teams. Sets prioritization of activities and follow up on actions.
+ Actively seeks collaboration and builds relationships with internal customers to improve overall outcomes that ensure the safety of products and patients.
+ Proactively identify and assess areas of improvements or risks and escalates issues in a timely manner.
+ Support internal and external audits as a subject matter expert.
+ Other essential duties as directed.
Job Requirements
Required:
+ Bachelor of Science degree in engineering or technical discipline.
+ Minimum of 8 years related experience, preferably in the medical device industry related to operations/design/quality engineering.
+ Experience in Post Market Surveillance, including leading or execution of Post Market Surveillance Plans and Periodic Safety Update Reports
+ Knowledge of EU 2017/745 (EU MDR), FDA QSR, ISO 13485 and other applicable industry standards
+ Travel up to 10% of the time domestically or internationally, availability to take evening and early morning teleconferences
Preferred:
+ Proven planning and organizational skills with background and experience in project management principles, practices, techniques, and tools
+ Strong analytical skills and the ability to operate effectively in a team environment
+ Ability to analyze complex problems, interpret operational needs, and develop integrated, creative solutions
+ Must be able to work independently, self-motivated, a sense of ownership with a strong sense of urgency to drive for results
+ Responds well under pressure and manages stress
+ Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance
+ Ability to gain cooperation and commitment from people through influence
+ Excellent verbal and written communication skills and comfortable presenting to small and large groups
+ Expert in Excel, Power Point, Visio, and Word
+ Experience in working with global teams
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 $101,523.00 - $142,132.00 / 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
