Our client is fast growth medical device company with an extensive product portfolio which is using proprietary biomaterials for several different application areas. The senior management team has a track record of multiple successful launches and commercial enterprises. Our client has excellent investment backing and is poised for commercialization. This is an excellent time to come on board and build a career path of growth and rewards.

To support the growing portfolio, they are seeking a Senior Quality Engineer to lead the design control process from concept through commercialization. You will collaborate with Research & Development, Manufacturing Operations, Regulatory, and Clinical personnel to support development projects, and support the Quality team to implement and improve the quality management system.

Responsibilities

· Understand and implement FDA QSR and ISO 14971, and ISO 13485

· Implement domestic and international regulatory standards (i.e. GMP, FDA QSR, ISO, MDD and MDR) in product requirements, design controls, V&V and operations

· Support design verification and validation test plans, protocols, procedures and reports and participate in cross functional formal design reviews and design transfer

· Lead the risk management process including PFMEA/FMEA/DFMEA, ensure that analyses track to requirements

· Create, revise and review SOPs and manufacturing documentation to maintain compliance to regulations and requirements

· Assist in establishing and revising specifications criteria for raw materials, in-process and final product

· Lead the supplier quality process

· Evaluate existing processes and scale-up activities for process improvements, process capability, and economy-of-scale efficiencies to improve cost-savings and product

· Update and keep proper Quality System records, reports and statistics

· Assist with product and process validation and verification

· Monitor and facilitate the timely completion of all quality planning activities

· Interact with regulatory bodies during inspections/audits

Requirements

· BS in Engineering or scientifically relevant discipline

· Five to 8 years’ experience in medical device quality, although an ambitious and driven applicant with less experience will be considered

· Thorough understanding of the Quality System Regulation, ISO 14971, ISO 13485

· Thorough knowledge of medical device quality management systems

· Thorough knowledge of risk management techniques

· Thorough knowledge of design control

· Knowledge of statistical techniques for sampling

· Knowledge of terminal sterilization process monitoring

· Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.

· ASQ certification (i.e., CQA, CQE) a plus.

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