Quality Analyst

Quality Analyst position in the STERIS Applied Sterilization Technologies (AST) Chester, NY facility, ensuring adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135, and other regulatory standards. This role involves leading complaint/CAPA investigations, supplier quality initiatives, and continuous improvement efforts using statistical techniques and quality principles.

Responsibilities

• Coordinate day-to-day tasks and provide technical support, mentoring, and oversight to Quality Technicians/Senior Quality Technicians.
• Oversee 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, manage customer communication, and lead 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 creation and revision of quality system policies and 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 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.

Skills

• Excellent problem-solving skills with a focus on identifying potential issues and continuous improvement.
• Experience working on cross-functional teams and independently.
• Strong organizational, oral, and written communication skills.
• Proficiency with PC applications including Excel, Word, and PowerPoint.
• Ability to work in a fast-paced, regulated environment with strict deadlines.
• Mathematical skills including practical application of fractions, percentages, ratios, proportions, and algebra.

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 company match.
• Maternity and paternity leave.
• Additional benefits including pet insurance discounts.
• Tuition reimbursement and continuing education programs.
• Opportunities for advancement in a stable, long-term career.

Pay

Pay range for this opportunity is $76,000 - $86,000. 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.

Schedule

This position requires working onsite in the Chester, NY facility from 8:00 am to 5:00 pm (or 8:30 am to 5:30 pm).