Quality Engineering Senior

Minnesota, Saint Cloud; 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.
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Patient Focus, Integrity, Innovation, Impact and Empathy.

The Senior Quality Engineer will develop, maintain, and support the company Quality System regulatory requirements and business strategy. Continuously improve Quality performance related to manufacturing and metrics related to the strength of the site Quality System. Leads complex projects. Mentors Quality Engineer for best practices for the use of Quality tools and methods. Can serve as a backup to the Management Representative for the site.
Participates in Cross-functional teams to support manufacturing representing Quality Engineering discipline.
Completes assigned Quality Engineering tasks to schedule.
Provides resident expertise in the application of Quality Sciences including statistics, data analysis, problem solving and the creation of system solutions.
Develops, maintains and reviews product risk management files, and provides guidance on application of risk management to Quality System processes (FMEAs, NCR risk, CAPA risk, etc.).
Assists others to lead and develop novel approaches within the Quality team.
Leads the implementation, compliance, and maintenance of standards (e.g., FDA CFR Title 21 §820, ISO 13485, ISO 14971) and Olympus Global Quality policies and procedures for the sites.
Trains location personnel on all aspects of the Quality System and regulatory standards.
Serves as a mentor and advisor for the Quality team to assist in developing Quality Engineering skills and capabilities.
Applies the requirements of the Quality System to processes, products, or services for the location.
Leads, supports, and guides the manufacturing line to address quality issues and resolution using the best Quality techniques and principles.
Leads Quality system elements such as but not limited to: Validation, Deviation, Data Trending, CAPA, Audits etc.
Monitors product and process performance metrics and acts upon trends with minimal guidance.
Authors, collaborates, and approves Quality System documentation including change orders for DHF, DMR, DHR, labels and labelling etc.
Support Supplier Quality Engineering to resolve Quality issues, providing information to and interfacing with suppliers as required.
Develops and drives measurable Quality improvements relating to products, process, and services.
Communicate significant issues or developments identified during Quality assurance activities and provide recommended process improvements to cross-functional teams (CFTs) and management.
Run reports to analyze Production and Complaint data and identify any significant trends.
Support the Quality Management System (QMS) by performing periodic product process and internal audits.
Bachelor's degree in engineering discipline or equivalent. 5 plus 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 regulatory requirements and international standards, including U.FDA QSR requirements, EU MDR 2017/745, Canada Medical Device requirements, ISO 13485:2016, and ISO 14971:2019, and the ability to educate others on related subject matter.
• Strong Quality Science skills including demonstrated statistics application and problem solving.
• 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.
• Working knowledge of problem-solving tools and root cause analysis techniques (i.e., FMEA, Pareto Analysis, Cause & Effect diagrams, 5-whys, Ishikawa diagrams, etc.)

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Offers onsite, hybrid and field work environments
Dedicated Training Resources and Learning & Development Programs
The anticipated base pay range for this full-time position in this location is $95,904.00 - $129,470.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

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. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus View phone number on us.fitly.work).

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) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)