Lead Quality Assurance Engineer

2 weeks ago


Northborough, Massachusetts, United States STERIS Canada Corporation Full time
Job Title: Senior Project Quality Engineer

Job Category: Quality

Location: Northborough, MA, US

Overview:

At STERIS Canada Corporation, we are dedicated to enhancing global health and safety through our innovative healthcare and life science solutions.

Position Overview

Due to internal advancements and opportunities for professional growth, 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, ensuring 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 enhancing product and service quality through statistical methods and established quality principles. You will also be responsible for planning and executing activities related to the development, implementation, maintenance, and continuous improvement of our 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 plans, designed experiments, capability studies, SPC, and trend analysis.
  • Lead and/or contribute to 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 elevate quality.
  • Oversee projects aimed at improving quality systems, product quality, and service quality.
  • Report on the effectiveness of the quality management system.
  • Contribute to strategic planning and conduct audits of internal and supplier quality systems.
  • Assist in external and internal quality system audits.
  • Educate other 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 responsibilities and objectives.
  • Ensure product integrity and quality by supporting the evaluation and disposition of nonconforming materials.
  • Perform additional duties as assigned.
Required Qualifications:
  • 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 on cross-functional teams and independently.
  • Proficient in PC applications, including Excel, Word, and PowerPoint.
Preferred Qualifications:
  • 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 a plus.
Skills:
  • Exceptional problem-solving abilities.
  • Strong organizational, verbal, and written communication skills.
What We Offer:

We provide an opportunity to be part of a company that invests in your long-term career. STERIS recognizes that our success is driven by our exceptional team members, and we reward hard work with competitive salaries, comprehensive healthcare benefits, tuition assistance, paid time off, holidays, 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 comply with local minimum wage laws, if higher than 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 diversity and inclusion in the workplace. We ensure 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, sexual orientation, gender identity, genetic information, or any other category protected by law.



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