We are a medical device company currently looking for a Manufacturing Quality Engineer (MQE).
The MQE is responsible for supporting all quality/regulatory engineering activities to support the product life cycle, from concept through commercialization, through sustaining changes, as part of a cross-functional development team.
This includes active participation in origination of design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and applicable documentation. Responsible for all aspects (product and process) related to the quality of the designated product line(s). This includes manufacturability of products, supplier manufacturing, and investigation of customer complaints. Develops, modifies, applies and maintains quality standards, and generates protocols and reports.
The MQE provides coaching to Design Engineer and Manufacturing personnel on Quality System Requirements and process improvement methodologies for their product families responsible for the quality assurance of all products, quality system management, and manufacturing process quality and customer problem resolution. The MQE is also responsible for supporting continuous improvement activities and all results related to product quality, performance and safety. This position reports to the Director of Quality.
A Bachelor of Science (BS) degree in Biomedical or Mechanical Engineering – (other science based technical degrees will be considered) with a minimum of 7 years of Quality/Regulatory experience in the medical device/pharmaceutical industry,
Or a Master’s of Science (MS) degree in Biomedical or Mechanical Engineering – other science based technical degrees will be considered with a minimum of 5 years of Quality/Regulatory experience in the medical device/pharmaceutical industry.
MUST have thorough understanding of Current Good Manufacturing Practices, Quality Systems, Regulatory Requirements, Validation Principles and Manufacturing Methods in a Medical Device/Pharmaceutical regulated environment (demonstrated knowledge and application of quality system regulations - 21CFR820, MDD, ISO - 13485, ISO - 14971 and other international standards).
Strong technical writing skills and ability to create technical protocols and reports as well as manufacturing inspection procedures. Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods.
Excellent oral and written communication skills are required. Salary is based on experience and knowledge. We offer a competitive benefits package. We are an equal opportunity employer.
Qualified applicants please send resume and cover letter to: email@example.com