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Lead Quality Assurance Engineer
2 months ago
Job Category: Quality
Location: Northborough, MA, US, 01532
Overview:
At STERIS Canada Corporation, we are dedicated to fostering a healthier and safer world through our innovative healthcare and life science solutions.
Position OverviewDue to internal advancements and opportunities for career development, STERIS is 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 encompass supporting complaint and CAPA investigations, enhancing supplier quality, overseeing production operations, and driving product and service quality improvements utilizing statistical methods and established quality principles. You will also plan and execute initiatives aimed at the development, implementation, maintenance, and continuous enhancement of STERIS quality systems.
Key Responsibilities:- Engage in cross-functional new product development teams focusing on the execution of quality strategies and design transitions.
- Formulate and implement statistically valid sampling methodologies, designed experiments, capability assessments, SPC, and trend evaluations.
- Lead and/or contribute to corrective actions and problem-solving initiatives related to processes and products.
- Continuously assess the existing quality management system and propose/implement enhancements as necessary.
- Analyze collected data to conduct statistical evaluations and suggest process/product modifications to elevate quality.
- Oversee projects aimed at enhancing quality systems, product quality, and service quality.
- Report on the efficacy of the quality management system.
- Participate in strategic planning and audits of both internal and supplier quality systems.
- Support external and internal quality system audits.
- Educate other STERIS personnel on quality principles, effective corrective measures, and valid statistical techniques.
- Collaborate with various departments and facilities within the organization on quality-related matters.
- Supervise Quality Engineers and other quality personnel in fulfilling their assigned responsibilities and objectives.
- Ensure product integrity and quality by supporting the evaluation and disposition of nonconforming materials.
- Perform additional duties as assigned.
- Bachelor's Degree in Engineering or a related technical discipline.
- 6+ years of combined experience in Quality Engineering and/or Quality Systems.
- 6+ years of experience in an ISO certified environment is mandatory.
- Experience working within cross-functional teams and independently.
- Proficient in PC applications, including Excel, Word, and PowerPoint.
- 6+ years of experience in the medical device or other regulated sectors is preferred.
- ASQ certification or familiarity with QSR/GMP regulations is advantageous.
- Experience with statistical analysis software and Visio is preferred.
- Exceptional problem-solving abilities.
- Proven organizational, verbal, and written communication skills.
We provide the opportunity to join a company that is committed to investing in your long-term success. STERIS recognizes that our achievements are driven by our remarkable team. We reward your dedication with competitive salaries, comprehensive healthcare benefits, tuition assistance, paid time off, holidays, a matching 401(k), annual merit increases, and incentive plans. We invite you to contribute to our ongoing success.
The compensation range for this position is [$97,000] - [$107,000].
Minimum pay rates will adhere to local minimum wage laws, if higher than the stated range. Compensation is determined by various factors, including local labor market conditions, relevant experience, education, professional certifications, and language proficiency.
STERIS is an Equal Opportunity Employer. We are dedicated to equal employment opportunities and affirmative action programs to ensure that individuals are recruited, hired, trained, transferred, and promoted in all job groups without regard to 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, or any other category protected by federal, state, or local law.
