Position SummaryThe Quality Engineer II in our Eden Prairie, MN location is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.
This position requires that you work onsite in our Eden Prairie facility Monday through Friday during core business hours 7am to 4 pm or 8am to 5pm. Must be available for occasional early morning calls with team in Germany. What You'll do as a Quality Engineer II - Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
- Develop and implement statistically valid sampling plans, design experiments, capability studies, SPC and trend analysis.
- Initiate and/or participate in process and product corrective actions and problem-solving activities.
- Update/establish documented work instructions as needed.
- Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
- Monitor and report on performance metrics.
- Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborate with other departments and facilities within the company on quality related issues.
- Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
- Perform quality system audits and provide guidance on corrective actions.
- Perform other duties as assigned.
The Experience, Skills and Abilities NeededRequired: - Bachelor's Degree in Engineering.
- Minimum of 3 years of related experience required (Manufacturing/Quality Engineering and/or Quality Systems).
- 3+ years of experience working in an ISO certified environment.
- Experience with medical device or other regulated industries.
- Ability to travel to local supplier sites up to 10%.
Preferred: - ASQ, Certification, preferred.
- Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.
- Knowledge of Track Wise, Windchill PLM, Grand Avenue or other similar systems.
- Experience with supplier controls, supplier audits or supplier monitoring.
- Knowledge of ISO 13485 regulations.
Other: - Shares technical knowledge with others in the team.
- Identifies technical problems and provides innovative solutions.
- Generates alternatives and takes reasonable risks while solving technical problems.
- Generates detailed, high-quality technical documentation to capture and communicate designs.
- Completes tasks on time with minimal supervision while identifying potential risks.
- Drives improvements in processes for better efficiency.
- Utilizes advanced tools and best practices to track product and process metrics.
- Mentors team members on timely task completion and actively participates in brainstorming sessions.
What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.
Here is just a brief overview of what we offer:
- Market Competitive pay
- Extensive Paid Time Off and added Holidays
- Excellent Healthcare, Dental and Vision benefits
- Long- and Short-Term Disability coverage
- 401(k) with a company match
- Maternity and Paternity Leave
- Additional add- on benefits / discounts for programs such as Pet Insurance
- Tuition Reimbursement and continuing education programs
- Excellent opportunities for advancement in a stable long-term career
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Pay range for this opportunity is $86,062.50 - $111,375.00. This position is eligible for bonus participation.
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits
Open until position is filled.
