Quality Analyst

Assist in administration of the quality management system at the STERIS Applied Sterilization Technologies (AST) Coon Rapids, Minnesota facility 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.

Responsibilities

• Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring, and oversight.
• Oversee all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
• Execute product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading associated non-conformance investigations.
• Initiate and/or participate in corrective actions, problem-solving, and continuous improvement activities.
• Perform internal audits at other AST facilities, including identification of non-compliances and report generation. Manage remediation of internal audit observations assigned by site Quality Manager.
• Manage creation of new quality system policies and procedures and revisions to existing policies/procedures.
• 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 within the company 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.
• Minimum of 1 year of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum of 1 year of experience working in an ISO-certified environment.

Preferred Qualifications

• Minimum of 1 year of experience with medical device or other regulated industries.
• Working knowledge of FDA QSR/EU GMP regulations.
• Excellent problem-solving skills with a focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral, and written communication skills.
• PC experience and working familiarity with desktop applications including Excel, Word, and PowerPoint.

Benefits

• Market-competitive pay.
• Extensive Paid Time Off and added holidays.
• Comprehensive healthcare, dental, and vision benefits.
• Long- and short-term disability coverage.
• 401(k) with a company match.
• Maternity and paternity leave.
• Additional add-on benefits/discounts for programs such as pet insurance.
• Tuition reimbursement and continuing education programs.
• Opportunities for advancement in a stable, long-term career.

Pay

Pay range for this opportunity is $76,000 - $91,000 annualized. 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.

Schedule

This is an onsite day shift position with a schedule of 7:00 am to 4:00 pm, Monday through Friday.