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Job Title:  Zone Director, Quality Systems

Req ID:  28272
Job Category:  Quality

Northborough, MA, US, 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

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.  This leadership position will partner with the Isomedix Operations Management team in the development of operating standards that are not only compliant with all relevant regulations but also outline sustainable processes that can be readily operational in both Radiation and Ethylene Oxide facilities.

Duties

1. Provide leadership and direction to the QS/RC Regional Managers and their staff to ensure the QS/RC activities across the business are consistent with our goals, and objectives. This is accomplished through the ongoing and systematic identification of opportunities for improvement and ensuring that corrective and preventive actions required as a result of internal and external audits, non-conformance, system deviations and Customer complaints are responded to in a manner which meets requirements as well as business objectives.

2. Lead by coaching, managing, motivating and monitoring the QS/RC Regional Managers and their staff as needed through ongoing performance feedback and formal reviews, as well as development initiatives which target individual strengths and weaknesses while delivering business results.

3. Partner with the Isomedix Quality and Regulatory Compliance Management team in the development and subsequent adherence to quality system standards. Lead the execution of these policies working in tandem with the Zone Director Quality System partner to train the team and require execution of these procedures at each Isomedix facility.

4. Create and critically assess the impact of each quality procedure on the daily operations of the business. Working alongside the Operations Management team identify opportunities for improvement and efficiency all while ensuring the spirit of the regulations that govern our business are never compromised.

5. Assist Isomedix Operations Management in establishing strategies designed to align Operations, Quality Systems, Sales and Customer requirements.

6. Apply regulatory knowledge and judgment to the evaluation of quality concerns as well as regulatory compliance issues.

7. Responsible for managing the FDA inspection process in each assigned facility working in tandem with the VP, Chief Compliance Officer to ensure that Inspector’s requests for information are met in a timely manner with the highest level of professionalism. Address any remediation required as a result of an inspection immediately with a corrective action plan to first direct the timely implementation at the inspected facility followed by a comprehensive assessment of the division to identify and correct systemic findings.

Duties - cont'd

8. Oversee the implementation of Dosimetry systems ensuring compliance with all applicable regulations and standards.

9. Facilitate consolidation and preparation of periodic management reviews for Corporate Quality & Regulatory leadership and Isomedix Operations leadership. In tandem with the Operations Leadership team, develop, track, and trend key measures that ensure regulatory compliance and Customer satisfaction through continuous improvement.

10. Strive for continuous improvement by analyzing new or alternative ways to improve systems, incorporating staff suggestions after analysis; responding to regulatory charges and utilizing various findings for the benefit of the organization.

Education Degree

  • Bachelor's Degree in Science or Other

Required Experience

Minimum of eight (8) 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.

Preferred Experience

Skills

  1. Expert 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.
  2. Demonstrated ability to motivate, train and develop a high performance team.
  3. Willingness to design and then demonstrate through your daily activities a model of continuous monitoring of our quality system activities to ensure compliance to documented standards.
  4. Comfortable confronting difficult situations and issues in an appropriate and timely manner.
  5. Self-starter with demonstrated organizational, project management, time management and problem-solving skills.
  6. Strong interpersonal skills – ability to work effectively across a matrix organization.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers 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.

Req ID:  28272
Job Category:  Quality

Northborough, MA, US, 01532


Nearest Major Market: Worcester

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