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VP Quality and Released Product

VP Quality and Released Product

Gateway RecruitingMinneapolis, MN, US
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Job Description

Job Description

Job Summary :

Responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes, releasing product engineering processes and documentation in compliance with domestic and international regulatory / quality requirements. Management Representative for the company.

Essential Functions (Including Regulatory Requirements) :

  • Maintain the Quality Management System to support compliance for facility certifications and registrations in accordance with applicable standards and regulations.
  • Establish and lead the newly created released product engineering (RPE) function
  • Schedule, participate, and assist in follow-up activities for internal audits, supplier audits, and quality / regulatory inspections.
  • Review and revise Quality System documentation to ensure compliance with domestic and international qualityand regulatory requirements specific to new and revised regulations and maintain the effectiveness of the QMS.
  • Maintain program to ensure adequate training of personnel on quality system documentation.
  • Work with the HR Department on companywide training activities.
  • Ensure employees are trained in the Quality Systems Regulation and key international regulations and standards.
  • Schedule, prepare documentation, and complete timely quality reviews and management review meetings.
  • Work with contract manufacturers to ensure that devices are manufactured in compliance with US and international quality system requirements.
  • Work with a cross-functional team to evaluate released device field performance, supplier's ongoing change requests, and overall maintenance of released devices in the marketplace.
  • Implement RPE programs and projects to maintain, improve, and support released devices in the market.
  • Create and maintain a strong working relationship with the PD team for the execution of projects and programs.
  • Assist in the management of the 3rd Party Logistics Supplier – HealthLink
  • Participate in product development team meetings with RPE inputs and oversite for quality and regulatory.
  • Identify and resolve quality / regulatory issues throughout the product development process to ensure successful audits and regulatory submissions.
  • Lead the complaint handling process, support determination of reportability of complaints to US and international regulatory agencies as required.
  • Maintain a functional CAPA system in compliance with applicable regulations.
  • Maintain infrastructure, maintenance, and calibration systems.
  • Oversee internal manufacturing and product evaluations.
  • Support supplier controls purchasing function.
  • Manage, supervise, and train staff, oversee projects ongoing within departments, and carry out departmental administrative duties.
  • Manage the document services function to ensure that quality systems documents, records, and regulatory submissions are controlled.
  • Manage the program for handling product returns, returned product evaluations (and repair / rework, where applicable), complaints, and customer feedback in accordance with internal policies and procedures.
  • Manage product release and non-conforming product activities.
  • Support PMS / PMCF / PSUR activities and requirements.
  • Maintain appropriate trending of data for all relevant QMS functions.

Knowledge / Educational Requirements :

  • Minimum bachelor's level degree.
  • 10-12 years of experience in Quality Assurance and / or Product Development Engineering in the implantable medical device industry.
  • Experience as a functional leader at the Director or VP level.
  • Good working knowledge of domestic and international requirements and regulations such as FDA, ISO, GMP, etc.
  • Skills and Abilities :

  • Excellent organizational skills and analytical and problem-solving abilities, strong verbal and writing skills, and good interpersonal and leadership skills.
  • Strong PC skills include Windows environment, Word, Excel, and the Internet.
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