21 days ago
Sr. Design Quality Engineer
The key things they are looking for are:
? Regulated industry experience (preferably medical)
? 2-4 years of experience in product development driving risk management processes (risk & hazard analysis, xFMEA, FMA, etc)
This position has the responsibility to provide Quality Engineering support to ensure the successful development of products and ongoing operational support. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to positively influence development efforts and ongoing manufacturing support as needed. In parallel, this person shall also ensure the products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems.
Duties will include identification of gaps in existing design history file and risk management file documentation as related to external requirements (standards and reg.s) and internal quality system procedures, as well as completion of documentation to efficiently close the gaps.
? Actively represent Quality Assurance function on product/process development teams.
? Provide guidance to Engineering staff and other personnel and ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.
? Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
? Lead or participate in design reviews to evaluate designs and to help identify alternative design solutions.
? Identify and manage risk throughout the development process with the use of Hazard Analysis, FMEAs and/or other risk management tools. This includes leading the Risk Management efforts of the design process and working with design team and management team on managing product and process risks.
? Creation, evaluation, and validation of product and process test methods.
? Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
? Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
? Contributes to design input requirements from experience with previously reported problems.
? Promotes continuous improvement in design control activities and use of quality tools with design team.
? Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet ?specifications.
? Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices.
? Comply with applicable FDA and international regulatory laws/standards and QA procedures.
? Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
? Other duties as assigned or required.
? All activities must be performed in compliance with the Quality System.
? Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
? All other duties as assigned.
? Travel requirement: 20-40%
? Bachelor?s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, Industrial Technology, etc.)
YEARS OF EXPERIENCE
? 4+ years of experience with a Bachelor?s Degree
? 2+ years of experience with a Master?s Degree
SPECIALIZED KNOWLEDGE REQUIRED
? Experience in a regulated industry
? Master?s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, Industrial technology, etc.)
? Experience in the Medical Device Industry.
? Self-motivated and committed to a team approach
? Strong interpersonal, organizational and project management skills
? Strong oral, presentation and technical writing skills
? Demonstrated skills in decision making ? preferably across a broad spectrum of Quality Engineering responsibilities
? Extensive knowledge of quality tools:
o Hazard Analysis
o Risk Analysis, Risk/Benefit
o Design, Process and Use FMEA
o Highly proficient in math and use of statistical techniques
o Design of experiments
o Root cause analysis
o Problem solving approaches
? Reading and correcting drawings
? Project management methods and tools
? Quality System Regulation (QSR)
? Medical Device Directives (MDD)
? ISO procedures / Other Nation & International Standards
? FDA requirements and guidance
? Good Manufacturing Practices (GMP)
? Good Laboratory Practices (GLP)
? Use of various tools, including microscopes, calipers, and other inspection equipment
? Knowledge of sampling methods
? Six Sigma background strongly desired.
? Certified Quality Engineer (CQE) / Certified Biomedical Auditor (CBA) preferred
? Mastery of relevant software programs preferred ? Microsoft Word, PowerPoint, Excel, and Project, and Minitab.
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