Principal Quality Engineer
Principal Quality Engineer
Posted on :
21-05-2025
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1 Vacancy
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Job Description
Responsibilities:
- Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a crossfunctional team for new product development of medical devices.
- Develop and implement methods and procedures for inspecting testing and evaluating the precision and accuracy of components/material/products and production equipment.
- Develop test plans inspect and assess materials compliance based on dimensional and attribute acceptance criteria while documenting and communicating inspection results.
- Determine optimal measurement devices to perform inspections. Understand AQL tables and how to select the correct sampling rate based on quality criteria.
- Apply knowledge of design control principles statistics process & systems validation and quality engineering techniques to positively influence projects and manufacturing.
- Utilize quality tools to include Risk analysis FMEA statistical techniques including sixsigma and DOE (design of experiments) root case analysis reading and correcting drawings.
- Lead the development and implementation of visual and physical inspections of injection molded mechanical electrical and packaging components to ensure they meet specifications.
- Assist Quality Engineers and manufacturing personnel with calibration activities which includes reviewing and retrieving calibrated equipment necessary for processing.
- Managing Root Cause Analysis activities stemming from MRB RMA and CAPA.
- Analysing/trending nonconformances through NCMRs and RMAs.
- Assist in supplier audits and visits as required.
- Assist in the manufacturing transfer process including the creation and completion of planning documentation DMR/DHR and validation protocols (IQ OQ PQ).
- Support other duties as assigned by manager.
- Bachelors degree required in Engineering Biomedical Engineering or Life Sciences.
- Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electromechanical devices is required.
- Experience with new product development required.
- Working knowledge of QSR MDD/MDR ISO13485 and ISO14971 is required.
- Experience in metrology required.
- Strong organizational skills detail oriented and the ability to meet changing deadlines on a fastmoving environment.
- Strong documentation capability for protocol and report generation and review.
- Ability to communicate effectively within a technical environment.
- Team player who celebrates winning together.
- No travel required.
- Must have Experience with New Product Development.
- Must have All required knowledge/skill on description. Here are some other experiences that are plus.
- Must have Design Quality Engineering.
- Must have Validation Protocols.
- Must have FMEA Risk analysis.
- Must have Supplier qualifications.
- Must have Mechanical Electric experience.
Employment Type
Full Time
Key Skills
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