Senior Market Quality Engineer - Olympus Corporation of the Americas
Westborough, MA
About the Job
Working Location: MASSACHUSETTS, WESTBOROUGH; TENNESSEE, BARTLETT
Workplace Flexibility: Field
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: _Integrity – Empathy – Agility – Unity – Long-Term View_
We deliver on our purpose and our core values by staying True to Life.
Job Description
The Senior Quality Engineer is responsible for CAPA ownership, execution, and support for Market Quality as required in close collaboration with other Complaint Handling teams in all applicable regions (Japan, EMEA etc.). This position may lead a team of SMEs in the execution of CAPA activities to ensure that actions are executed in compliance with all applicable global regulations and laws. This position may also be responsible for the creation and/or revision of local/ global processes to support the global Market Quality organization meet all applicable regulations and laws.
Job Duties
+ Responsible and accountable for CAPA ownership, execution, and support for all applicable global Market Quality CAPA’s. This includes creation, management, and execution of local/global Market Quality procedures, work instructions, practices, and compliance to CAPA procedures, working in a cross-functional team with other Market Quality management/departments.
+ Responsible to support as required cross functional teams (Market Quality, COE, COE MDR Team) that receive CAPA actions. The teams will collaborate to develop appropriate actions to eliminate the non-conformances. · Create, review, and approve release of changes to QMS documentation. Coordinate with other functions and sites to ensure timely and accurate completion and efficient change processing.
+ Ensures that the market quality processes are standardized throughout the business and ensures that they are implemented consistently and correctly.
+ Identifies areas of focus through data driven trending and brings solutions to management.
+ Support and participate in NCR process.
+ Support and participate in internal and external Quality Audits (including notified bodies and health authorities) and ensure related corrective action activities are completed in a robust and timely manner. Act as Audit Finding coordinator.
+ Provides resident expertise in the application of Quality Sciences including, statistics, data analysis, problem solving and the creation of system solutions for Quality System issues
+ All Other Essential Duties as assigned by Management.
Job Qualifications
Required:
+ Bachelor of Science, medical, engineering, or scientific discipline
+ Minimum of 5 years’ experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR ) compliance and quality assurance.
+ Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses.
+ Demonstrated experience in developing and leading a top performing Quality team is required
+ Competent understanding of medical device regulations both domestic and international with specific expertise in; Regulator Inspections, Complaints and Regulatory reporting, and Corrective and Preventive Actions (CAPA).
+ Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms.
+ Up to 25% domestic travel, if not co-located with an Olympus manufacturing and/or service center.
Why join Olympus?
_Here, people matter—our health, our happiness, and our lives._
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive Medical, Dental, Visions coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free virtual live and on-demand wellness classes
+ Work-life balance supportive culture with hybrid and remote roles
+ 12 Paid Holidays
+ Educational Assistance
+ Parental Leave and Adoption Assistance
+ Volunteering and charitable donation match programs
+ Diversity & Inclusion Programs including Colleague Affinity Networks
+ On-Site Child Daycare, Café, Fitness Center
_*US Only_
_Limited locations_
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .
The anticipated base pay range for this full-time position working at this location is $83,187.00 - $112,302.00 / 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.
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
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.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
Workplace Flexibility: Field
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: _Integrity – Empathy – Agility – Unity – Long-Term View_
We deliver on our purpose and our core values by staying True to Life.
Job Description
The Senior Quality Engineer is responsible for CAPA ownership, execution, and support for Market Quality as required in close collaboration with other Complaint Handling teams in all applicable regions (Japan, EMEA etc.). This position may lead a team of SMEs in the execution of CAPA activities to ensure that actions are executed in compliance with all applicable global regulations and laws. This position may also be responsible for the creation and/or revision of local/ global processes to support the global Market Quality organization meet all applicable regulations and laws.
Job Duties
+ Responsible and accountable for CAPA ownership, execution, and support for all applicable global Market Quality CAPA’s. This includes creation, management, and execution of local/global Market Quality procedures, work instructions, practices, and compliance to CAPA procedures, working in a cross-functional team with other Market Quality management/departments.
+ Responsible to support as required cross functional teams (Market Quality, COE, COE MDR Team) that receive CAPA actions. The teams will collaborate to develop appropriate actions to eliminate the non-conformances. · Create, review, and approve release of changes to QMS documentation. Coordinate with other functions and sites to ensure timely and accurate completion and efficient change processing.
+ Ensures that the market quality processes are standardized throughout the business and ensures that they are implemented consistently and correctly.
+ Identifies areas of focus through data driven trending and brings solutions to management.
+ Support and participate in NCR process.
+ Support and participate in internal and external Quality Audits (including notified bodies and health authorities) and ensure related corrective action activities are completed in a robust and timely manner. Act as Audit Finding coordinator.
+ Provides resident expertise in the application of Quality Sciences including, statistics, data analysis, problem solving and the creation of system solutions for Quality System issues
+ All Other Essential Duties as assigned by Management.
Job Qualifications
Required:
+ Bachelor of Science, medical, engineering, or scientific discipline
+ Minimum of 5 years’ experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR ) compliance and quality assurance.
+ Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses.
+ Demonstrated experience in developing and leading a top performing Quality team is required
+ Competent understanding of medical device regulations both domestic and international with specific expertise in; Regulator Inspections, Complaints and Regulatory reporting, and Corrective and Preventive Actions (CAPA).
+ Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms.
+ Up to 25% domestic travel, if not co-located with an Olympus manufacturing and/or service center.
Why join Olympus?
_Here, people matter—our health, our happiness, and our lives._
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive Medical, Dental, Visions coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free virtual live and on-demand wellness classes
+ Work-life balance supportive culture with hybrid and remote roles
+ 12 Paid Holidays
+ Educational Assistance
+ Parental Leave and Adoption Assistance
+ Volunteering and charitable donation match programs
+ Diversity & Inclusion Programs including Colleague Affinity Networks
+ On-Site Child Daycare, Café, Fitness Center
_*US Only_
_Limited locations_
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .
The anticipated base pay range for this full-time position working at this location is $83,187.00 - $112,302.00 / 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.
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
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.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
Source : Olympus Corporation of the Americas