Manager, Medical Device Manufacturing and Development
Our client is seeking an experienced Manufacturing Manager to join our Medical Device Manufacturing and Development team. The primary role of this position will be the oversight of manufacturing kits based upon our patented platform in support of RUO, IUO and IVD applications. Tasks will include the development, implementation, and maintenance of manufacturing documents, processes, and activities. Additionally, the Manufacturing and Development Manager is responsible for coordinating design transfer activities related to materials, QC Test Methods, manufacturing processes and supporting the transfer of activities from R&D to Manufacturing while ensuring compliance to quality objectives. You will be expected to work cross-functionally with R&D, Assay Development, Quality, Regulatory Affairs, vendors and contract manufacturers.
Responsibilities and Duties:
- Oversee design transfer from R&D to Manufacturing
- Maintain active BOMs for each product
- Produce and manage plans, reports, specifications, SOPs, forms, and other documentation to support Manufacturing and/or Manufacturing Development activities
- Ensure processes, documents, materials and equipment are in compliance with applicable regulatory requirements including ISO13485, ISO 14971 and cGMP
- Generate batch records
- Work closely with QA to maintain compliance
- Lead process validation related activities for the design, qualification and continued process verification of Resolution Bioscience manufacturing process, including identification of opportunities for improvement.
- Lead the generation, maintenance and coordination of the Master Validation Plan.
- Participates in investigations related to Nonconformance and/or Corrective and Preventive Actions related to manufacturing.
Qualifications and Skills:
- Requires a Bachelor's Degree in Biochemistry, Microbiology or Engineering related field
- At least 5 years of relevant experience with a minimum of 2 years management experience
- At least 5 years of relevant experience working under FDA QSR/ISO 13485 and GMP regulations
- Extensive experience with molecular biology techniques
- Experience with risk assessment ISO 14971
- Strong data analysis and troubleshooting skills
- Familiarity with auditing practices
- Experience with IQ/OQ/PQ
- Familiarity with Manufacturing Engineering (Bills of Material, Batch Sizes, Costing, etc.)
- Strong organizational and communication skills, including technical writing