Job Summary:

Responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes, released 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 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 quality and 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.