Senior Product Quality Engineer

STERIS Canada Corporation; Minneapolis (MN); On-site; USD 97,000 - 127,000; Full time

Job summary

A leading company in healthcare solutions is seeking a Senior Product Quality Engineer in Minneapolis. This role involves overseeing quality systems, leading investigations, and developing improvement plans. Candidates should have a strong engineering background and substantial experience in Quality Engineering, particularly in regulated environments. STERIS offers competitive pay and comprehensive benefits to support employee well-being and development.

Benefits

Market Competitive pay

Extensive Paid Time Off and Holidays

Excellent Healthcare, Dental and Vision benefits

401(k) with a company match

Tuition Reimbursement

Qualifications

• Minimum of 6 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Experience in an ISO certified environment required.
• Familiarity with statistical analysis software preferred.

Responsibilities

• Manage processes and lead projects to maintain quality systems.
• Lead corrective actions and supplier audits for product quality.
• Collaborate with cross-functional teams on quality issues.

Skills

Problem Solving

Analytical Skills

Organizational Skills

Communication Skills

Statistical Analysis

Education

Bachelor’s degree in Engineering

Job description

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At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Senior Product Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

This role requires onsite work in our Plymouth, Minnesota location with up to 10% domestic travel to other STERIS locations or to visit supplier sites as required.

What You’ll do as a Senior Product Quality Engineer

• Serve as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
• Lead process and product corrective actions and problem-solving activities.
• Review the current quality system and recommend / implement improvements as needed.
• Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
• Lead projects focused on quality system, product quality and service quality improvements.
• Develop analyses and reports on the performance of the quality system.
• Lead supplier audits and corrective actions.
• Lead and support internal and external quality system audits.
• 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.
• Supervise Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
• Maintain product integrity and quality through the evaluation and disposition of nonconforming materials and processes.

The Experience, Skills and Abilities Needed

Required:

• Bachelor’s degree in Engineering or related technical field.
• Minimum of 6 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum of 6 years of experience working in an ISO certified environment required.
• Excellent problem-solving skills
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Ability to travel domestically up to 10 % to STERIS locations or to visit supplier sites as required.

Preferred:

• Experience working as a Product Quality Engineer in a regulated industry.
• Experience with statistical analysis software and Visio.
• Minimum of 6 years of experience with medical device or other regulated industries.
• ASQ, QSR or familiarity with QSR/GMP regulations.

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 rate for this opportunity is $97,962 to $126,775. This position is eligible forbonus 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

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Nearest Major Market: Minneapolis
Job Segment: Senior Quality Engineer, Quality Engineer, Medical Device Engineer, Medical Device, Manufacturing Engineer, Engineering, Healthcare