Quality Engineer II, Medical Device
Our client is a Medical Device manufacturer. Their growth has been extremely good and as described by the HA “There is a lot of enthusiasm for what we do here; it’s a truly great place to work or I wouldn’t be here!” This is a hands-on role where, on any given day, you’ll be active on the production floor, interacting with project teams involving other departments, and regularly interacting with suppliers (electronically and in-person) to ensure the client’s production demands are met.
As a QE, you are expected to hit the ground running, capable of managing your own projects and experienced enough to move beyond the “Silo” approach. You will be challenged every day across the breadth of the demands of a device QS as it relates to Quality and expected to navigate the challenge.
- Leads/participates on product/process improvement teams
- Directly responsible to develop and monitor analytics for major production lines
- Creates metrics for SPC of critical-to-quality specifications
- Provides support from NPD to Production ensuring compliance to the QS, and regulatory agencies
- Executes complete V&V studies (IQ/OQ/PQ) on equipment and processes, writes protocols, and reports
- Interacts with management to define KPI’s and regularly reports on same
- Manages or participates in CAPA’s based upon Post Market results as compared to production/supplier data
- Writes and/or updates WI’s, DMR’s, PFMECA’s and Quality Plans
- Actively participates in or leads product registration activities with Marketing and Sales
- Centrally responsible for successful supplier quality relationships especially Risk Mitigation as it relates to finished goods
- Is generally responsible for Supplier Quality including auditing, pre-assessments, self-surveys, process improvement/cost reduction opportunities, and assisting operations & engineering in new supplier evaluation
- Visits supplier locations as required for auditing, resolution of quality issues, etc.
- Assist operations & engineering departments in the evaluation and qualification of new suppliers.
- Travel to supplier locations to facilitate resolution of quality problems.
- Provides mentoring/coaching in Risk Analysis, e.g. PFMEA as it applies to existing and NPD, at suppliers
- Knows Lean/Six Sigma principles including, at a minimum, DOE, SPC, PFMEA, and Process Capability
- Interacts with Purchasing to ensure Supplier Performance Criteria are clearly defined via Agreements and being met through Performance Metric Measurement
- Bachelor’s Degree in an appropriate Engineering or other technical discipline is required
- 6+ years as a Quality Engineer in the Medical Device space
- Certified Quality Engineer (CQE) and/or Certified Supplier Quality Professional (CSQP) and Certified Quality Auditor (CQA) preferred
- Previous experience with manufacturing or product quality related data analytics such as process capabilities, SPC, pareto, or other related data
- Strong foundational knowledge in ISO 13485 and 21 CFR 820
- Background in machining, casting/forging, and 3-D manufacturing as they relate to med device a plus