Quality & Regulatory Manager

Job Description

Job Description

Primo Medical Group is an industry leader in the development, manufacture and assembly of quality medical devices and precision machined components, currently with four locations.

We are looking for a hands-on Quality & Regulatory Manager to join a medical device company based south of Boston. Our innovative company offers a competitive salary, excellent benefits and opportunity for professional advancement.

Essential Duties and Responsibilities:

Reporting directly to the Chief Operating Officer, the Quality & Regulatory Manager will manage the quality management system and regulatory requirements for the company.

• Responsible for maintaining Quality Management System according to FDA QSR and ISO 13485 regulations. Leads audits relative to such regulations and implements continuous improvement initiatives to maintain a robust Quality Management System.
• Manage FDA regulatory filings, including the maintenance of existing products and new product launches. Work closely with Principal Engineers to determine regulatory pathways and prepare FDA submissions.
• Partner with product development teams to ensure Design Control Procedures are followed.
• Work with Customer Service, Sales Personnel and necessary departments to document, investigate and close Customer Complaints.
• Responsible for proper execution of company Corrective and Preventive Action process for CAPAs stemming from audits, customer complaints or other sources.
• Record and trend Quality Management System activities for presentation to the management team including CAPA, Nonconformance, Complaint, and audits, etc.
• Present information at Management Review.
• Maintains up to date Quality Management System procedures and ensures completion of documented training. Implement procedure changes to quality system documents using the DCR system.
• Identifies Critical Suppliers. Maintains Approved Supplier Files including supplier qualification & continued evaluation. Performs supplier audits as required.

Education/Experience:

• Relevant Bachelor’s Degree required; Masters preferred.
• 5-7 plus years related experience in medical device industry, at least 3 years direct responsibility for implementation and upholding of complete medical device quality and regulatory management systems.
• Thorough understanding of FDA Quality System Regulations 21 CFR 820 and ISO 13485 standards & requirements.
• Excellent writing skills with ability to prepare FDA filings and write technical reports.
• Strong interpersonal skills are needed to interact with all levels of the company.

Company DescriptionPrimo Medical Group, Inc. is an industry leader in the development, manufacture and assembly of quality medical devices and precision machined components for our own product lines, as well as helping major industry players do the same with theirs. Our unique mix of clients and projects will provide you with a challenging career with numerous opportunities for growth.

Primo Medical Group, Inc. offers the most comprehensive outsourcing solutions to the medical device market, including OEM product distribution services, engineering services, precision component production, finished goods assembly, refurbishment of medical devices, reusable surgical kit management, warehousing, logistics and complete supply chain management.

Primo Medical Group is guided by its customer's requests for Continuous Improvement in Product Quality, Product Design and Customer Service. We are problem solvers, and we recognize that our success depends on the degree to which we fulfill customer expectations. Your role in our organization will be critical to maintaining and strengthening customer satisfaction by providing your technical and leadership skills to successfully bring their products to market.

Company Description

Primo Medical Group, Inc. is an industry leader in the development, manufacture and assembly of quality medical devices and precision machined components for our own product lines, as well as helping major industry players do the same with theirs. Our unique mix of clients and projects will provide you with a challenging career with numerous opportunities for growth.\r\n\r\nPrimo Medical Group, Inc. offers the most comprehensive outsourcing solutions to the medical device market, including OEM product distribution services, engineering services, precision component production, finished goods assembly, refurbishment of medical devices, reusable surgical kit management, warehousing, logistics and complete supply chain management.\r\n\r\nPrimo Medical Group is guided by its customer's requests for Continuous Improvement in Product Quality, Product Design and Customer Service. We are problem solvers, and we recognize that our success depends on the degree to which we fulfill customer expectations. Your role in our organization will be critical to maintaining and strengthening customer satisfaction by providing your technical and leadership skills to successfully bring their products to market.