Rapidly-growing medical device design house and manufacturing facility, with an innovative and energetic team that is committed to providing high-quality
products to our customers and patients. We are seeking a Senior Product Quality Engineer that will be instrumental in applying best practices to ensure that our materials, components, processes, and manufacturing techniques produce high-quality, reliable products that exceed our customers' expectations.
Key Responsibilities • Integrate quality into manufacturing processes as a value added (real-time) support
function, performing root cause analysis, driving data-based continuous quality
improvements, and building strong customer relationships. • Ensure the successful integration of quality assurance, risk mitigation, and regulatory
compliance into device design, development, and manufacturing processes throughout
the product lifecycle. • Participates in design control and evaluates changes to design and/or manufacturing
process for impact to DHF. Leads and executes activities to close any gaps, such as
additional verification testing or updates to risk documentation. • Assists with product and process risk assessment activities, including hazard analysis and
design/process failure modes & effects analysis (DFMEA/PFMEA). • Participates in product and process qualification and evaluation activities not limited to
but including complaint investigation, first article, engineering studies, gage R&R,
regression analysis, SPC, and DOE. • Develops and implements methods for sampling, inspection, defect recognition, product
testing and evaluation, and SPC trending utilizing statistical, engineering and quality
knowledge. • Support the timely handling of investigations, risk assessments, deviations, NCRs and
CAPAs. • Support internal and external audits as a device and QMS Subject Matter Expert. • Leadership and mentoring responsibility for promoting and implementing best in class
Quality Management Systems, manufacturing processes, statistical techniques, and
QMS software solutions.
Qualifications • Bachelor's degree in a scientific or engineering field is required. • Minimum 5+ years' experience in a quality engineering role in the medical device
industry, or a related industry with manufacturing & assembly processes. • Excellent written and verbal communication skills. • Proficiency with standard office productivity suite and data analysis software, LMS and
eQMS software familiarity is a plus. • ASQ CQE preferred • High level of competence in statistical techniques, control charts, sampling plans, quality
costs, design of experiments, correlation, regression, analysis of variance, probability,
etc. • Experience in medical device design control, risk management, validation, and product
lifecycle • Experience with FDA GMP practices, CAPA and non-conforming material processes • Working knowledge and application of device regulations, including 21 CFR 820, ISO
13485, and ISO 14971. Knowledge of MDSAP, EU MDD/MDR a plus. • Ability to manage multiple projects within various disciplines, in a fast-paced
environment. • Self-motivated and capable of working cross-functionally with minimal supervision. • Demonstrated ability to assess and provide technical, statistical, and quality guidance
throughout the organization to ensure high quality, compliant products. • Must be detail oriented with strong leadership skills and excellent interpersonal,