The mission of the Regulatory Affairs and Quality Compliance function is to implement repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. This includes designing and championing efficient and effective processes across all facilities to ensure adherence to all quality system regulations including but not limited to:
- 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
- 21 CFR Section 1271.150 – Current Good Tissue Practice (cGTP)
- 21 CFR Part 11 – Electronic Records, Electronic Signatures
- Health Canada, Food and Drug Regulations, Division 2, Part C: Good Manufacturing Practices - Drugs
- ISO 13485: Medical devices – Quality management systems,
- EN ISO 11135-1:2007 – Sterilization of healthcare products – Ethylene oxide
- EN ISO 11137-1:2006 – Sterilization of healthcare products - Radiation
- ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories [Biotest Labs]
This management position will support the Regional QS/RC Manager in the development and implementation of the quality systems within the facility that they are based. In addition, the position will be responsible for all quality matters pertinent to the quality system in their facility to maintain sustainable quality processes.
- Provide leadership and direction to the quality staff within their designated facility and to ensure the QS/RC activities are consistent with the goals and objectives of the Isomedix organization. This is accomplished through the ongoing implementation of improvements as directed by the Zone Director, Quality Systems and QS/RC Regional Manager and ensuring that corrective and preventive actions within the facility are implemented timely and as designed.
- Lead by coaching, managing, and monitoring their staff through ongoing performance feedback and formal reviews, as well as demonstrating best practices in job function and development initiatives which target individual strengths and weaknesses.
- Support the implementation of quality system standards at each Isomedix facility within their region through direction to the QS/RC Analysts and Technicians in their facility.
- Monitor facility non-conformances, Customer complaints and audit findings from internal and external audits. Perform periodic audits within the assigned facility and participate in other facilities as needed to support continuous monitoring of our quality system.
- Lead Customer and notified body quality/regulatory audits at their facility. Provide regular feedback and communication on the status of active audits to the Zone Director, Quality Systems and QS/RC Regional Manager.
- Collaborate with operations management within their assigned facility to develop sustainable remediation action plans. Actively participate in assigned facility projects alongside the Operations Management team to identify opportunities for improvement and efficiency all while ensuring the spirit of the regulations that govern our business are never compromised.
- Apply regulatory knowledge and judgment to the evaluation of quality concerns as well as regulatory compliance issues.
Duties - cont'd
- Responsible for leading support during the FDA inspection process on-site at their facility. Works with the Zone Director, Quality Systems, QS/RC Regional Manager, and Isomedix Quality and Regulatory Compliance Management to assist in gathering Inspector’s requests for information in a timely manner with the highest level of professionalism. Implement any remediation required as a result of an inspection immediately with a corrective action plan within their facility.
- Implement Dosimetry or Biological Indicator systems within their facility ensuring compliance with all applicable regulations and standards.
- Support the continuous improvement efforts within the facility by participating in quality and performance improvement projects. Provide feedback from quality staff to the QS/RC Regional Manager, Zone Director Quality Systems and Isomedix Quality and Regulatory Compliance Management on opportunities for improvement.
- Monitor QS/RC facility expenses to ensure actual expenses are managed with the plan and the subsequent forecasts by quarter.
- Support a safe, clean and secure working environment by supporting procedures, rules and regulations; supports plant safety committees that evaluate plant machinery, equipment and working conditions.
- Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
- Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
- Exhibits a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency.
- Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher level management and performs other duties as assigned.
- Bachelor's Degree
- Minimum of six (6) years professional experience, preferably including regulatory affairs, legal or governmental compliance matters, quality systems, internal auditing, applicable scientific or technical functions and/or healthcare industry experience.
- Working knowledge of regulations and standards, including, but not limited to, U.S. FDA device QSR and cGMP regulations, EU medical device requirements, Canadian device and drug compliance requirements and ISO 13485 medical device standard.
- Ability to motivate, train and develop staff within their facility.
- Willingness to demonstrate through your daily activities a model of continuous monitoring of our quality system activities to ensure compliance to documented standards.
- Demonstrated organizational, project management, time management and problemsolving skills.
- Demonstrated ability to analyze data and performance metrics.
- Ability to work independently under general guidelines and supervision from the QS/RC Regional Manage.