Quality Manager - Medical Device
As the Quality Manager, you will be responsible for developing and implementing a quality management system and for driving the development of a quality function that will be core to the company’s success.
We are looking for bright, hands-on individuals who are interested in making a difference in a dynamic and exciting entrepreneurial environment.
• Lead quality system development, implementation, and execution to US and international standards, including compliance to ISO13485:2016, EU 2017/745 (MDR) and US FDA 21 CFR requirements.
• Serve as Quality System Management Representative (QSMR) with responsibility for compiling required quality system performance metrics and reporting the effectiveness of the QMS, to top management and identify any need for improvements to maintain compliance with regulations.
• Manage the Internal and External QMS Audit program; ensuring audit compliance and adequate follow-up to audit nonconformances.
• Develop and qualify test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products.
• Provide oversight for supplier quality management, including qualification of suppliers, supplier corrective actions and conducting sub-contractors and component supplier audits.
• Drive continuous improvement and CAPA projects, and proactively identify and implement best-in-class quality engineering practices.
• Support risk management programs to ensure compliance with ISO 14971 and partner with engineering to drive design control processes.
• Develop validation strategies in partnership with Manufacturing Engineering to support production transfer of design projects.
• Review and approve documents including: Manufacturing batch records in support of product release; SOPs, Process Validation Protocols and Reports, and Quality Agreements.
• Support the maintenance of a robust Environmental Monitoring program for the company’s controlled environment room areas.
• Support the maintenance and reporting of routine product bioburden and endotoxin monitoring for all applicable products.
• Maintain an effective and compliant site Change Control and Document Control process.
• Proactively investigate and analyze customer complaints, and oversee problem reporting to regulatory agencies.
• Coach and develop team members and supervise/train quality technicians.
Qualifications and Experience
The ideal candidate will be a motivated individual looking to grow professionally in a fast-paced environment. Strong analytical skills, excellent knowledge of theoretical and practical fundamentals, and a solid ability to work on multiple projects simultaneously are required.
• BS in Engineering (Biomedical, Mechanical, Industrial, Operations, or Quality) from a top tier institution preferred.
• 5+ years of work experience in medical device industry. Start-up or small company experience highly preferred.
• Demonstrated success developing and implementing quality management systems.
• Exceptional working knowledge of US and international medical device regulations (knowledge of EU regulations is a must).
• Prior experience with the US FDA IDE clinical investigations and EU Clinical Evaluations in support of CE mark are highly desirable.
• Training in EU MDR or prior experience in leading MDR transition projects a plus.
• Experience in new product development (NPD) and production transfer.
• Flexibility and willingness to adapt, strong team orientation and ability to lead in a cross-functional environment are a must.
• CQE or equivalent certifications a plus.
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
Beacon Hill PharmaBeacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.