Share this Job

Job Title:  Lead, Quality & Regulatory Compliance Auditor - Remote

Req ID:  32007
Job Category:  Quality

Mentor, OH, US, 44122

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 STERIS Quality & Regulatory Compliance function is to implement repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. This includes evaluating the relevance to all STERIS facilities and products and implementing efficient and effective processes to ensure adherence to applicable regulations and standards.

This position requires 20% domestic and international travel.

The Lead, Quality and Regulatory Compliance Auditor must have expert working knowledge of the following regulations and standards:

•    21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
•    21 CFR Part 803 – Medical Device Reporting
•    21 CFR Part 806 – Medical Device Corrections and Removals
•    21 CFR Part 7 – Enforcement Policy, Subpart C – Recalls
•    21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
•    21 CFR Part 11 – Electronic Records, Electronic Signatures
•    ISO 13485 Medical devices – Quality management systems
•    ISO 9001 Quality management systems – Requirements
•    EN ISO 11135-1 Sterilization of healthcare products – Ethylene Oxide
•    EN ISO 11137-1 Sterilization of healthcare products – Radiation
•    ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
•    ISO 14971 Application of Risk Management to Medical Devices
•    EU Medical Device Directive
•    EU Medical Device Regulation
•    EU MEDDEV 2 12-1: Guidelines on a Medical Device Vigilance System

The compliance activities require close work with STERIS corporate domestic and international staff and Customers and U.S and foreign government agencies.
 

Duties

  • Responsible for conducting data analysis and identifying areas of compliance risk and vulnerability
  • Ensures compliance with regulations and controls by examining and analysing records, reports, operating practices, and documentation; recommends opportunities to strengthen the internal control structure
  • Responsible for reporting to Senior Management the results of data gathering, audit results, and process improvements implemented as a result of continuous monitoring program
  • Design, implement, and maintain audit programs to fulfil compliance audits
  • Will manage the schedule and execution of compliance audits
  • Responsible for reviewing procedures and conduct appropriate compliance audit examination
  • Will manage and approve completion of established remediation for identified areas of risk
  • Effectively manage and communicate the development of Compliance policies and procedures with strong working knowledge of policy development and approval process
  • Manage the outputs of the investigation and research of compliance issues
  • Research, interpret, and perform efficient gap analysis for new and updated regulations and standards
  • Responsible for leading and directing other staff in the performance of compliance audits at STERIS facilities as well as unscheduled audits as directed by Quality & Regulatory Compliance Senior Management
  • Lead the organizational staff by coaching, managing, motivating, monitoring, and evaluating them through ongoing performance feedback and formal reviews, as well as development initiatives which target individual strengths and weaknesses while delivering business results
  • Review test plans and validation documentation for IT systems
  • Assist in compliance projects as needed

 

Required Experience

  • Four (4) year degree required, preferably with general business core, risk management, project management, regulatory, or internal audit
  • Minimum of 2 years of regulatory compliance auditor 
  • Minimum of 2 years of supervisory / people management experience 
  • Excellent PC skills, including Microsoft Office applications
  • Experience working with and effectively leading cross-functional team
  • Professional certifications and regulatory training certificates in relevant disciplines are desirable, as is completion of or actively working towards an advanced degree in a relevant discipline.
  • Strong leadership skills including ability to lead and collaborate
  • Demonstrated ability to motivate, train, and develop a high-performance team
  • Ability to balance multiple high priority responsibilities on-time and effectively
  • Can comfortably and effectively confront difficult situations and issues in a timely and appropriate manner
  • 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
  • Strong oral and written communication skills
  • Bilingual skills are a plus, but not required

#LI SA2

What we offer

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

  • Competitive pay
  • Annual merit bonus and incentive plans
  • Medical, vision, prescription, dental and life insurance
  • 401(k) with a company match
  • Paid vacation time and paid holidays
  • On site parking and electrical vehicle charging stations
  • Free shuttle from public transportation to plant
  • Tuition assistance
  • Opportunities for advancement

 

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:  32007
Job Category:  Quality

Mentor, OH, US, 44122


Nearest Major Market: Cleveland

Job Segment: Medical Device, Internal Audit, Risk Management, Healthcare, Finance, Research, Quality