Quality Analyst

About the role

The Quality Analyst assists in administering the quality management system at a site to ensure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135, and other applicable regulatory standards. This role leads complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives, and countermeasures using statistical techniques and other accepted quality principles. The Analyst executes activities related to the development, implementation, maintenance, and continuous improvement of STERIS quality systems, and supports production and quality operations through problem-solving investigations, pre-reviews, and final acceptance of processing runs with non-conformances.

Responsibilities

• Coordinate day-to-day tasks and provide technical support, mentoring, and oversight for Quality Technicians/Senior Quality Technicians.
• Oversee all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
• Execute product and/or report releases for processing runs/lab samples containing non-conformances, including managing customer communication and leading non-conformance investigations.
• Initiate and/or participate in corrective actions, problem-solving, and continuous improvement activities.
• Perform internal audits at other AST facilities, identify non-compliances, and generate reports; manage remediation of internal audit observations.
• Manage the creation of new quality system policies and procedures and revisions to existing ones.
• Review collected data to perform statistical analysis and recommend process changes to improve quality.
• Monitor and report on performance metrics.
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborate with other departments and facilities on quality-related issues.
• Lead quality system programs (e.g., calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management).
• Ensure external and internal requirements are met according to documented policies, procedures, standards, and regulations.
• Perform other duties as assigned.

Requirements

• Bachelor’s Degree in a scientific or related technical field.
• 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 1-5 years of experience with medical device or other regulated industries preferred.
• 1-5 years of experience working in an ISO-certified environment required.
• Working knowledge of FDA QSR/EU GMP regulations strongly preferred.

Benefits

• Market-competitive pay.
• Extensive paid time off and 9 additional holidays.
• Comprehensive healthcare, dental, and vision benefits.
• Long/short-term disability coverage.
• 401(K) with company match.
• Maternity and parental leave.
• Additional add-on benefits/discounts (e.g., pet insurance).
• Tuition reimbursement and continued educational programs.
• Opportunities for advancement in a stable, long-term career.

Pay

Pay range for this opportunity is $85,000 - $93,000. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than the range listed. Pay rates are based on factors including local labor market costs, years of relevant experience, education, professional certifications, and foreign language fluency.