Description
QUALITY ENGINEERPOSITION RESPONSIBILITIES INCLUDE:
Manage supplier quality activities such as qualification, audits and bulk materials, quality metrics monitoring/trending/non-conformances in partnership with Manufacturing Engineering. Chair materials and vendor review boards.
Manage raw materials, in-coming quality control activities and provide hands-on support as necessary; develop and implement sampling plans, acceptance and release test methods, specifications and criteria.
Provide support for test methods development, implementation and validation for in-process, and release testing and associated documentation.
Develop and implement analysis and trending methods for IQC and QC data.
Support Product Development with knowledge transfer activities to ensure compliance to internal quality requirements and design control procedures (documentation, test methods validation, V&V activities).
Support process validation and equipment validation activities to ensure compliance to internal quality requirements.
Manage critical quality control equipment validation.
Manage preventive maintenance and calibration program.
Provide technical expertise to produce dossier for regulatory submissions.
EDUCATION & SKILLS REQUIREMENTS:
MS (or BS with equivalent experience) with relevant experience in a Life Science Curriculum (Biochemistry, Chemistry, Materials Science, or Medical Devices).
6+ years of experience in quality, product development or process development within an industrial environment, in a FDA and/or ISO 13485 regulated medical device setting, with knowledge of regulations. Prefer experience with in vitro diagnostic products.
Expert understanding and use of statistical methods for analyzing data, developing sampling plans and acceptance criteria, and designing experiments.