Senior Quality Engineer
About The Position
The Senior Quality Engineer manages processes and leads projects to maintain and improve the quality system in accordance with applicable standards and regulations, including ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR. The role leads complaint and CAPA investigations, supplier quality improvement actions, production and process control improvements, and product and service quality improvements using statistical techniques and accepted quality principles. The position plans and executes the development, implementation, maintenance, and continual improvement of STERIS quality systems. The role is onsite daily, with hours of operation from 8 a.m. to 5 p.m., and supervises Quality Engineers and other Quality staff.
Requirements
- Bachelor's degree in Engineering.
- At least 5 years of related experience in Manufacturing/Quality Engineering and/or Quality Systems.
- At least 5 years of experience working in an ISO-certified environment.
Nice To Haves
- Experience in medical device or other regulated industries.
- ASQ certification, QMSR experience, or familiarity with QMSR/GMP regulations.
Responsibilities
- Serve as a core team member on cross-functional new product and service development teams, focusing on execution of quality plans and design/service transfer.
- Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC, and trend analysis to support product and service improvements.
- Lead process and product corrective actions and problem-solving activities.
- Review the current quality system and recommend and implement improvements as needed.
- Use data and statistical analysis to recommend process and product changes that improve quality.
- Lead projects focused on quality system, product quality, and service quality improvements.
- Develop analyses and reports on quality system performance.
- Lead supplier audits and corrective actions.
- Lead and support internal and external quality system audits.
- Instruct employees in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborate with other departments and company facilities on quality-related issues.
- Supervise Quality Engineers and other Quality staff in carrying out assigned duties and objectives.
- Maintain product integrity and quality by evaluating and dispositioning nonconforming materials and processes.
- Perform other duties as assigned.
Benefits
- Market-competitive pay and eligibility for bonus participation.
- Extensive paid time off and additional holidays.
- Healthcare, dental, and vision benefits.
- Long- and short-term disability coverage.
- 401(k) with company match.
- Maternity and paternity leave.
- Additional benefits and discounts, including pet insurance.
- Tuition reimbursement and continuing education programs.
- Opportunities for advancement in a stable, long-term career.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
