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Quality Systems and Regulatory Manager

2 months ago

Norwood, United States Tekscan Full time

The Quality System and Regulatory Manager will report directly to the VP of Operations and is responsible for the design and implementation of policies, programs, procedures, and initiatives to ensure quality standards are met. The candidate will also have a focus on ensuring that the Quality Management Systems are adequately maintained, and the company is compliant with regulatory bodies.

 

Responsibilities:

  • Manage all activities relating to compliance with Quality Systems ISO 13485 regulations
  • Represent the Company during all audits (ISO, FDA, UL, Intertek etc.)
  • Provide training, tools and techniques to ensure awareness of ISO13485 standards
  • Arrange for ISO 13485 awareness training for new employees
  • Plan and coordinate internal quality audits and ensure that internal audit findings and recommendations are implemented
  • Ensure CAPA, nonconformance, complaint handling, recall and field actions, adverse event handling and audit programs are following current regulatory and reporting requirements
  • Lead Tekscan personnel in root cause analysis and implementation activities, ensuring that corrective actions are thoroughly investigated and corrected
  • Investigate and drive process improvement by taking a proactive approach to implement preventative actions.
  • Report to Tekscan management team on the performance of the Quality Management System based on existing quality objectives
  • Define and establish quality procedures, standards and specifications
  • Work with Purchasing to establish and monitor quality requirements from external suppliers
  • Manage documentation of change control workflow with Engineering and Operations teams
  • Engage with Product Management to ensure that Tekscan’s medical device technical files are complete and current, and any regular reviews are carried out
  • Coordinate with other employees to ensure that the quality system is functioning and effective
  • Monitor Regulatory developments in FDA, Federal Register, International Committees and other Regulatory guidance documents then assess impact on new and marketed products. Identify changes as required for labeling, manufacturing, marketing, engineering, product manuals, clinical protocols and other documentation for Regulatory Compliance
  • Coordinate registrations with relevant regulatory bodies and Authorized Representative

Interest In:

  • Interact with Regulatory Agencies to ensure that all products engineered, manufactured, or distributed by the Company comply with global regulations for risk, safety, labeling, literature and clinical protocols for Regulatory Compliance. Ensure designs meet all Regulatory requirements, reliability specifications, and performance objectives in Compliance with UL, CSA, IEC, CE Mark, EMC and other directives/standards. Ensure all reliability activities comply with industry standards and Regulatory requirements.
  • Support U.S. FDA and International Regulatory Compliance
  • Provide expertise in translating Regulatory requirements into practical, workable plans and ensures that the organization is adequately trained to these requirements. Ensure that Regulatory Compliance plans are established to guide Quality, Design (electrical, mechanical, software), Manufacturing/test engineering, and Technical Publications functions. Manage product risk control plans, Compliance testing, verification and validation testing and monitors developments in the industry to assure continued Compliance. Facilitate cross-functional project teams on validation tests and participate in design reviews providing guidance on Regulatory, Risk and Compliance requirements

Skills:

  • Continuous improvement mindset
  • Detail-oriented
  • Excellent written and oral communication skills in English with an ability to communicate technical concepts to people with a variety of backgrounds
  • Excellent verbal and written skills for communication of technical criteria to a variety of internal and external audiences
  • Proficiency using Microsoft 365 tools, ideally with Sharepoint and MS Teams experience

 

Experience/Education:

  • Bachelor’s Degree in Quality Management, Engineering, Business Administration or equivalent
  • Minimum 5 years experience as a Quality Manager managing ISO 13485 or other regulated quality management system
  • Prefer compliance experience in an FDA-regulated industry
  • Any additional training in Quality related fields is advantageous

 

Tekscan, Inc. proudly supports Affirmative Action and is an Equal Opportunity Employer committed to workforce diversity. Applicants are encouraged to confidentially self-identify when applying. Only applicants whose profiles closely match requirements will be contacted during the search.