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Job Title:  Lead, Quality Systems & Regulatory Compliance

Req ID:  16444
Job Category:  Quality
Country:  US
State:  MA
City:  Northborough
Zip:  01532
Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

 

This position will support the Regional QS/RC Manager in the implementation of the quality systems within the facility that they are based. Function as the facility acting QS/RC Manager while the Regional QS/RC Manager is out of the facility.  The mission of the Quality Systems and Regulatory Compliance function is to implement repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and quality 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
  • 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

 

Duties
  • Provide support to the Regional QS/RC Manager within their designated facility. Assume the acting role of site QS/RC Manager while the Regional QS/RC Manager is traveling.
  • Lead the site QS/RC Analysts and/or QS/RC Technicians by coaching, directing activities, assigning tasks, training, monitoring performance, and ensuring adherence to department standards; continuously monitoring of the quality system activities ensuring compliance to established procedures.
  • Supports the Regional Manager QS/RC in the implementation of quality system standards within the facility along with the site and Regional team.
  • Actively monitor facility compliance with established quality system standards through monitoring of non-conformances, Customer complaints and performing regular quality audits.
  • Responsible for leading Customer and notified body quality/regulatory audits within the facility and as needed to other facilities within the zone. Provide regular feedback and communication on the status of active audits to the Regional QS/RC Manager and facility operations team.
  • Collaborate with the Regional QS/RC Manager and operations management within the facility to develop sustainable remediation action plans. Actively participate in assigned facility projects alongside the Operations Management and Regional QS/RC Manager 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.
  • Responsible for supporting the FDA inspection process on-site in assigned facility. Works with the Regional QS/RC Manager and Operations Management to assist in gathering Inspector’s requests for information in a timely manner with the highest level of professionalism. Assist in implementation of any remediation required as a result of an inspection immediately with a corrective action plan.
  • Assist with implementation of Dosimetry or Biological Indicator systems within the facility ensuring compliance with all applicable regulations and standards.
Duties - cont'd
  • Support the continuous improvement efforts within the facility and the organization through participating in quality and performance improvement projects. Provide feedback from facility QS/RC Team to the QS/RC Regional Manager for improvement, alternative ways to improve systems, staff suggestions; and responding to regulatory charges.
  • 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.
Education Degree
  • Bachelor's Degree
Required Experience
  • Minimum of five (5) 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.
  • 5 years of working knowledge of regulations and standards, including, but not limited to, U.S. FDA device QSR and cGMP regulations, EU medical device requirements, and ISO 13485 medical device standard.
  • Ability to motivate, train and develop QS/RC Analysts and Technicians.
  • Can comfortably and effectively confront difficult situations and issues in a timely and appropriate manner.
  • Experienced in working effectively on cross-functional teams; able to lead cross-functional team when required.
  • Self-starter with demonstrated organizational, project management, time management and problem-solving skills is preferred.
  • Demonstrated ability to balance multiple high priority responsibilities on-time and effectively.
  • Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
  • Demonstrate through your daily activities a model of continuous monitoring of our quality system activities to ensure compliance to documented standards.
  • Demonstrated ability to project manage, to time manage and to problem-solve.
  • Demonstrated ability to analyze data and performance measures.
  • Ability to work independently under general guidelines and supervision from the QS/RC Regional Manger.
  • Strong interpersonal skills required.

 

STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.


Nearest Major Market: Worcester

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