Senior Quality Assurance Engineer

3 days ago

Minneapolis, Minnesota, United States Olympus Corporation of the Americas Full time
Job Title: Senior Quality Assurance Engineer

At Olympus Corporation of the Americas, we are seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our Quality and Regulatory Affairs department, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.

Key Responsibilities:
  • Develop, maintain, and support the company Quality System, regulatory requirements, and business strategy.
  • Lead complex projects and mentor less experienced engineers in best practices for Quality tools and methods.
  • Participate in Cross-Functional Teams to support new product development, procurement, manufacturing, and represent the Quality Engineering discipline.
  • Complete assigned Quality Engineering tasks to schedule and lead the promotion of Quality and Regulatory requirements.
  • Develop new approaches to solve problems identified as part of the team and assist others to lead and develop novel approaches within the 5E teams.
  • Lead the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures for the site.
  • Train location personnel on all aspects of the Quality System and regulatory standards.
  • Serve as a mentor and advisor for the Quality team to assist in developing Quality Engineering skills and capabilities.
  • Apply the requirements of the Quality System to processes, products, or services for the location and lead, support, and guide the manufacturing line to address quality issues and resolution using the best Quality techniques and principles.
  • Develop and maintain the validation and verification strategy for new and existing products and processes and lead the development and maintenance of Master Validation Plans.
  • Participate in the CAPA process as required as an assignee or project team member and monitor product and process performance metrics and act upon trends with minimal guidance.
  • Author, collaborate, and approve Quality System documentation including change orders, DHF, DMR, DHR, labels, and labelling, etc.
  • Conduct internal, vendor, and process audits to schedule and interface with suppliers to resolve Quality issues.
  • Develop and drive measurable Quality improvements relating to products, processes, and services.
Requirements:
  • Bachelor's degree in Engineering discipline or equivalent. Master's Degree preferred.
  • Minimum of 8 years related experience, preferably in the medical device industry related to process/quality engineering.
  • Viewed as an expert in the quality field.
  • Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO, and the ability to educate others on related subjects.
  • Strong Quality Science skills including demonstrated statistics application and problem-solving.
Preferred:
  • Leadership experience; proven ability to lead and manage cross-functional teams, effectively communicate with all levels of management, and drive effective change.
  • Excellent verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management.
  • Proven Project Management skills, with ability to manage cross-functional team and produce results.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization and/or guidance exists.
Why Join Olympus?

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/.

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 https://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 HRComplianceManager@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-695-9687).

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