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 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
• Minimum 3-5 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,
collaboration and communication skills.
