Supplier Quality Engineer I
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. The position is based in Plymouth, MN and requires onsite work between the hours of 8am to 5pm, with up to 10% domestic travel to visit supplier sites.
Responsibilities
- Participate in cross-functional new product development teams with focus on product/service quality and Quality System compliance.
- Develop and implement statistically valid sampling plans, designed 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 supplier audits and quality system audits; provide guidance on corrective actions.
- Perform other duties as assigned.
Requirements
- Bachelor's Degree in Engineering.
- Minimum of 1 year of related experience (Manufacturing/Quality Engineering and/or Quality Systems).
- Minimum of 1 year of experience working in an ISO certified environment.
- Ability to travel domestically up to 10%.
Preferred Qualifications
- Experience with medical device or other regulated industries.
- Experience with ISO 13485.
- Experience with Supplier Quality working with production suppliers impacting product quality.
- Certification with ASQ, QSR, or familiarity with QSR/GMP regulations.
- Experience with SAP.
- Experience with Quality Management Systems (QMS).
- Experience with Data Analytics.
- Experience with statistical analysis software and Visio.
Benefits
- Market competitive pay.
- Extensive Paid Time Off and added Holidays.
- Healthcare, Dental, and Vision benefits.
- Long- and Short-Term Disability coverage.
- 401(k) with a company match.
- Maternity and Paternity Leave.
- Pet Insurance.
- Tuition Reimbursement and continuing education programs.
- Opportunities for advancement in a stable long-term career.
Pay
Onsite pay range for this opportunity is $80,000 to $95,000. 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.
Schedule
This position requires onsite work in Plymouth, MN between the hours of 8am to 5pm.