- Flexible work schedule
- Global medical device manufacturer
About Our Client
Our client is a Medical Device Manufacturer that focuses on surgical technologies with customers like Smith & Nephew and Medtronic. They have grown rapidly over the last 5 years and continue to expand their product lines. They seek a motivated Quality Engineer that will report to their Quality Manager
- 80,000 SF Facility
- 100+ CNC Mill, Lathes
- 20+ New Product Lines
- Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
- Leads and implements various product and process improvement methodologies.
- Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Leads in the completion and maintenance of risk analysis.
- Leads generation and completion of protocols and reports for test method validations.
- Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
- Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- Bachelor's degree required; STEM (Science, Technology, Engineering, or Mathematics) related field, equivalent experience, and ASQ certification accepted.
- Working Knowledge of the 21 CFR 820 QSR, ISO 13485:2016, ISO 9001:2015
- Knowledge of engineering concepts as they relate to a manufacturing organization.
- Intermediate SPC/Data analysis skills and proven ability to perform DOE, FMEA, ANOVA, and Gage R&R analysis
- Experience using standard quality tools i.e. Flow Charts, Pareto Charts, Histogram, Control Charts, Ishikawa Diagram, 5 Why's
- Ability to successfully use basic office software applications (specifically MS Excel, MS Word, and MS Outlook)
What's on Offer
- Competitive base salary, dependent on experience, between $90,000 and $110,000
- Sign-on Bonus Potential
- 3% 401k Match
- Medical, dental and vision insurance through Blue Cross Blue Shield - ELIGIBLE DAY 1
- 15 days of Vacation
- 5 Sick Days
- 10 Paid Holidays
- Tuition Reimbursement
- Pet insurance, Legal Insurance