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Regulatory Compliance Engineer
2 months ago
UFP Technologies is a leading designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. As an important link in the medical device supply chain, UFP is a valued outsource partner to most of the top medical device manufacturers in the world.
The Company's single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants.
Benefits Package- Medical, Dental, Vision, Life, Disability Insurance
- 401K with a matching contribution
- Paid time off, Paid holidays, Employee discounts and much more
As a Quality Engineer at UFP Technologies, you will provide quality engineering technical support to Quality, Manufacturing, and R&D Engineers in corrective actions, investigation of nonconforming product, process control, statistical analysis, customer complaints, component validation, product measurement and testing, product launch in a cGMP & GDP environment, product certification, ISO 9001, ISO 13485, and AS 9100 audits.
Key Responsibilities- Supports, upholds and enforces compliance with ISO 9001, ISO 13485 and AS9100 regulations.
- Investigates and documents customer returns, complaints and nonconforming products.
- Implements measurable, effective corrective & preventive actions.
- Provides instruction, guidance and direction for manufacturing, engineering, materials, customers and suppliers in quality performance measurement.
- Provides program launch support at UFPT and customer facilities.
- Contributes to Lean Manufacturing and 5-S initiatives.
- Establishes and supports metrology & calibration program.
- Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality events.
- Performs supplier approvals assessments per Approved Supplier List requirements.
- Supports product development and production transfer activities.
- Translates product requirements into inspection criteria and process capability.
- Supports QMS internal audits and supplier / customer site audits.
- Writes work instructions and procedures.
- Improves and monitors inspection processes.
- Supports ISO 9001, ISO 13485, and AS 9100 certifications.
- Supports Project Leader's in performing FAIs.
- Generates bright cost saving / quality improving ideas.
- Continuously explores new ways to improve our business and services.
- Provides program launch support.
- Establishes and supports metrology & calibration program.
- Supports product development and production transfer activities.
- Performs other similar duties as required by responsibility, necessity or as requested.
- Bachelor's degree in Quality Assurance, Engineering, or Technology, plus 5 years of quality or manufacturing experience in regulated industry (i.e. Medical Device or Pharmaceutical).
- Quality Engineer Certification (CQE); plus 10 years' experience will be considered.
- Experience in ISO 13485 and 21 CFR Part 820 required.
- Experience in ISO 9001; or AS 9100 preferred.
- Thorough understanding of statistical process control and process capability is required.
- Cleanroom experience is required.
- Certification in Geometric Dimensioning & Tolerancing (GD&T) is preferred.
- cGMP experience is preferred.
- Occasional travel may be required.
