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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 enhancing the health and safety of our global community through innovative healthcare and life science solutions.
Position OverviewDue to internal advancements and growth opportunities, we are seeking a Senior Quality Engineer. In this role, you will be tasked with developing, maintaining, and enhancing the quality management system in compliance with standards such as ISO 9001, ISO 13485, MDSAP, and FDA 21 CFR Part 820. Your responsibilities will include supporting investigations related to complaints and corrective actions, improving supplier quality, and ensuring operational production and process controls meet the highest standards of quality.
Key Responsibilities:- Engage in cross-functional teams for new product development, focusing on quality plan execution and design transfer.
- Create and implement statistically valid sampling plans, design experiments, conduct capability studies, and perform trend analysis.
- Lead and participate in corrective actions and problem-solving initiatives for processes and products.
- Continuously assess the quality management system and propose enhancements as necessary.
- Analyze collected data to recommend process and product modifications aimed at quality improvement.
- Oversee projects that target enhancements in quality systems, product quality, and service quality.
- Report on the effectiveness of the quality management system.
- Participate in strategic planning and conduct audits of both internal and supplier quality systems.
- Support 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.
- Supervise Quality Engineers and other quality personnel in fulfilling their assigned tasks 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 experience in Quality Engineering and/or Quality Systems.
- 6+ years of experience in an ISO certified environment is mandatory.
- Experience working in cross-functional teams and independently.
- Proficient in PC applications, including Excel, Word, and PowerPoint.
- 6+ years of experience in the medical device or regulated industries is preferred.
- Familiarity with ASQ, QSR, or QSR/GMP regulations is advantageous.
- Experience with statistical analysis software and Visio is a plus.
- Exceptional problem-solving abilities.
- Strong organizational, verbal, and written communication skills.
We provide an opportunity for long-term career development within a company that values its employees. STERIS Canada Corporation recognizes that our success is driven by our talented workforce, and we reward hard work with competitive salaries, comprehensive healthcare benefits, tuition assistance, paid time off, holiday pay, a matching 401(k), and annual merit and incentive plans.
Compensation: The pay range for this position is [$97,000] - [$107,000].
Minimum pay rates will adhere to local minimum wage laws if they exceed 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, committed to ensuring that all individuals are recruited, hired, trained, and promoted 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 law.
