Quality Analyst (Mon Fri)

The Quality Analyst in the STERIS Applied Sterilization Technologies (AST) Chester NY facility is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001 ISO 13485 FDA 21 CFR Part 820/211 EU GMPs ISO 17025 ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Analyst leads complaint/CAPA investigations supplier quality improvement initiatives continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. The Quality Analyst executes activities concerned with the development implementation maintenance and continuous improvement of STERIS quality systems. The Analyst also supports production and quality operations by coordinating and performing problem-solving investigations pre-reviews and final acceptance/run release of processing runs that contain non-conformances.

The Quality Analyst is responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations dosimetry results generation of test methods audits scheduling validations record keeping and reporting.

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

• Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support mentoring and oversight.
• Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
• Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance including management of Customer communication and leading the 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. Responsible for managing 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 (i.e. calibration maintenance training CAPA complaints non-conformances supplier quality management review operational qualifications document control change control risk management etc.).
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies procedures standards and regulations.
• Perform other duties as assigned.

Required:

• Bachelors degree (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 required.

Preferred:

• Minimum of 1 year experience with medical device or other regulated industries preferred.
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.

Other:

• Excellent problem-solving skills
• 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 communications skills.
• Must have PC experience as well as working familiarity of desktop 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.

We value our employees and are committed to providing a comprehensive benefits package that supports your health wellbeing and financial future.

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent 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
• Excellent opportunities for advancement in a stable long-term career

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