Lead Quality Assurance Engineer
2 weeks 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 growth opportunities, we are seeking a Senior Quality Engineer. In this role, you will be tasked with the development, maintenance, and enhancement of our 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 investigations related to complaints and corrective actions, enhancing supplier quality, and improving product and service quality through statistical methods and established quality principles. You will also plan and execute activities aimed at the continuous improvement of STERIS quality systems.
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 strategies, designed experiments, capability studies, SPC, and trend analyses.
- Lead and participate in corrective actions and problem-solving initiatives for processes and products.
- Continuously assess the current quality system and propose/implement necessary enhancements.
- Analyze collected data to perform statistical evaluations and suggest process/product modifications to enhance quality.
- Lead projects aimed at improving 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 employees on quality principles, effective corrective actions, and valid statistical methodologies.
- Collaborate with various departments and facilities on quality-related matters.
- Supervise Quality Engineers and other quality personnel in fulfilling their assigned duties 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 essential.
- Experience working on cross-functional teams and independently.
- Proficient in PC usage and familiar with desktop applications such as Excel, Word, and PowerPoint.
- 6+ years of experience in the medical device or other regulated industries is preferred.
- Familiarity with ASQ, QSR, or QSR/GMP regulations is advantageous.
- Experience with statistical analysis software and Visio is preferred.
- Exceptional problem-solving abilities.
- Demonstrated strong organizational, oral, and written communication skills.
We provide an opportunity to be part of a company that invests in your long-term growth. STERIS values its employees and recognizes their contributions through competitive salaries, comprehensive healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit increases, and incentive plans.
Pay Range: [$97,000] - [$107,000].
Minimum pay rates will adhere to local minimums if they exceed the listed 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 fostering an inclusive workplace. We uphold equal employment opportunities and affirmative action programs to ensure recruitment, hiring, training, and promotion practices are free from discrimination based on race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex, sexual orientation, gender identity, genetic information, and any other category protected by law.
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