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Lead Quality Assurance Engineer
2 months ago
Job Category: Quality
Location: Northborough, MA, US
Overview:
At STERIS Canada Corporation, we are dedicated to fostering a healthier and safer environment through our innovative healthcare and life science solutions worldwide.
Position OverviewDue to internal advancements and opportunities for career progression, we are seeking a Senior Quality Engineer. In this role, you will be tasked with the development, maintenance, and enhancement of the quality management system in alignment with standards such as ISO 9001, ISO 13485, MDSAP, and FDA 21 CFR Part 820. Your responsibilities will include supporting complaint and CAPA investigations, enhancing supplier quality, overseeing production operations, and driving product and service quality improvements through statistical methodologies and established quality principles. You will also plan and execute initiatives related to the development, implementation, maintenance, and continuous enhancement of our quality systems.
Key Responsibilities:- Engage in cross-functional teams for new product development, focusing on quality plan execution and design transfer.
- Formulate and implement statistically valid sampling strategies, designed experiments, capability studies, SPC, and trend analysis.
- Lead and participate in corrective actions and problem-solving initiatives related to processes and products.
- Continuously assess the existing quality system and propose/implement necessary enhancements.
- Analyze collected data to perform statistical evaluations and suggest process/product modifications to elevate quality.
- Direct projects aimed at improving quality systems, product quality, and service quality.
- Report on the efficacy of the quality management system.
- Contribute to strategic planning and audits of both internal and supplier quality systems.
- Assist in external and internal quality system audits.
- Educate fellow employees on quality principles, effective corrective actions, and valid statistical methods.
- Collaborate with various departments and facilities on quality-related matters.
- Oversee Quality Engineers and other quality personnel in fulfilling their assigned responsibilities and objectives.
- Ensure product integrity and quality by supporting the evaluation and resolution of nonconforming materials.
- Perform additional duties as assigned.
- Bachelor's Degree in Engineering or a related technical discipline.
- Over 6 years of combined experience in Quality Engineering and/or Quality Systems.
- Minimum of 6 years of experience in an ISO certified environment.
- Experience working in cross-functional teams and independently.
- Proficient in PC applications, including Excel, Word, and PowerPoint.
- 6+ years of experience in medical device or other regulated industries.
- Familiarity with ASQ, QSR, or QSR/GMP regulations.
- Experience with statistical analysis software and Visio.
- Exceptional problem-solving abilities.
- Strong organizational, oral, and written communication skills.
We provide an opportunity to be part of a company that invests in your long-term growth. At STERIS, our success is driven by our exceptional people, and we recognize their contributions through competitive salaries, comprehensive healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit increases, and incentive plans.
Compensation: The pay range for this position is [$97,000] - [$107,000].
Pay rates are determined by various factors, including local labor market conditions, relevant experience, education, professional certifications, and language proficiency.
STERIS is an Equal Opportunity Employer, committed to fostering an inclusive workplace and ensuring that all individuals are treated fairly in recruitment, hiring, training, and promotion processes, regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex, sexual orientation, gender identity, genetic information, or any other category protected by law.
