- Plans and conducts the analysis, inspection, and/or integration of test methods to assure the quality of purchased and assembled components and finished goods.
- Manages inspection workflow and participates in the assessment of returned products, incoming, in-process and finished goods.
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
- Utilizes statistical analysis techniques to determine product acceptance and sampling plans, evaluate process capabilities, and develop tolerance limits.
- Advises on design changes and their implementation and provides training, tools, and techniques to enable others to achieve quality.
- Coordinates the documentation review, problem solving and calibration for test equipment.
- Helps to develop, track and report quality metrics.
- Drives NCR process including root cause analysis, timely disposition and closure. Leads and/or participates in MRB meetings, identifies trends and develops and administers technical investigation and corrective action programs to resolve recurring quality problems.
Product Development & Operations
- Contributes to and participates as a resource in the development and implementation of product test plans including Verification and Validation of products and processes.
- Serves as a liaison to design, procurement, and manufacturing engineering.
- Performs standard quality engineering reviews of design documentation, quality records, and supplier documentation for compliance.
- Works with Operations to identify, analyze, and address supplier quality issues.
- Minimum 5 years’ experience as a Quality Engineer in the medical device industry
BA/BS degree in science or related technical field.
- Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485.
- Demonstrated skills in statistical analysis.
- Strong computer skills.
- Individual must have a hands-on approach, and succinct communication skills.
- Experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier).
- Strong organizational and time management skills.
- Experience with CAPA, , and risk management.
- Experience with complaint investigation and field action preferred.
- CQE, preferred.
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