Quality Assurance Specialist
2 months ago
The Quality Assurance Specialist is responsible for ensuring the quality of products and services at STERIS, a leading global provider of infection prevention solutions. This role involves coordinating day-to-day tasks and direction for Quality Technicians, overseeing product and report pre-reviews and releases, and executing corrective actions and problem-solving activities.
Key Responsibilities- Coordinate and direct Quality Technicians in their daily tasks and activities.
- Oversee the review and release of products and reports, ensuring compliance with regulatory standards.
- Investigate and resolve non-conformances, complaints, and quality issues.
- Develop and implement quality systems and procedures to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Monitor and report on quality metrics and performance indicators.
- Provide training and guidance to Quality Technicians on quality principles and procedures.
- Bachelor's Degree in a relevant field.
- 1-5 years of experience in quality assurance, regulatory compliance, or a related field.
- Working knowledge of FDA QSR/EU GMP regulations.
- Experience working in an ISO-certified environment.
- Master's Degree in a relevant field.
- 5+ years of experience in quality assurance, regulatory compliance, or a related field.
- Experience working in a medical device or regulated industry.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills.
- Ability to work in a fast-paced, regulated environment.
- Mathematical skills, including practical application of fractions, percentages, ratios, proportions, and algebra.
This is an onsite schedule position. The schedule is: M-F, dayshift hours. 5% - 10% international and domestic travel.
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