Summary: This position is responsible for the management of Post- Market process and the centralized Quality Engineering responsibilities.
Post-Market responsibilities include Risk Analysis, Safety Review Board, Complaint Handling and Product Evaluation processes.
This includes directing personnel and managing all activities associated with safety review board, risk assessment, complaint handling, and the evaluation of returned product resulting from customer complaints.
The individual shall ensure complete investigation of complaints related to malfunction, defects or product use issues.
In addition, this position will work with the Returns and Technical Services areas to identify recurring quality issues and drive corrective action.
This position will also manage the process for issue escalation to Safety Review Board for assessment of risk and whether further escalation is required.
Centralized Quality Engineering responsibilities include Design Quality and Purchasing Controls processes.
This includes directing a group of quality engineers and managing all activities associated with this area of the quality system.
The individual shall ensure compliant and efficient operation while supporting projects critical to the company’s success.
Essential Functions:
· Manage the Complaint Handling Unit, who is responsible for evaluation, investigation, and reportability decisions and filing for products marketed in North America
· Manage the Quality Engineering team responsible for Design Quality and Purchasing Controls for products designed, supplied, or marketed in North America
· Ensure efficient and consistent involvement in design quality functions ensuring that appropriate input is provided
· Manage and document supplier requirements, Approved Supplier List, supplier audits, and follow-up activities
· Ensure efficient and consistent handling of complaints and FDA and Health Canada reportability decisions
· Manage and document the complaint handling and returned product evaluation process including the escalation of potential product safety related issues.
· Manage the Safety Review Board and Risk Analysis processes to ensure appropriate risk assessment and escalation determination for identified issues
· Develop and document training plans, SOPs, work instructions, technical documents that support the functional goals of the group in a compliant, efficient and consistent manner.
· Work with and engage Engineering, Supplier Quality, Plant Quality and other groups as needed to identify recurring issues and drive corrective action and improvement.
· Ensure that all required training is identified for and completed by all direct reports.
· Participate in internal and external audits including the FDA relative to all activities, reports and files associated with the product evaluation and escalation process.
· Evaluate staffing needs and costs; identifies, hires and promotes individuals with the right skills and competencies necessary to achieve superior results.
· Develop a team environment that values diversity and uses various individual’s strengths to the benefit of the team.
· Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.
Qualifications:
· Bachelor Degree in Science or Engineering; Master Degree Preferred
· Minimum 5 years of experience working in a medical device industry with some supervisory experience.
· Experience managing projects and directing and leading the team members.
· Strong communication, analytical, organization and management skills
· Proficiency with MS Office, MS Project, Visio, electronic document management
· Knowledge of 21CFR 820 (QSR) and ISO 13485
· Experience with FDA audits desirable
· High ethical standards and integrity
An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet
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