MedTech Quality Engineer – GMP, ISO, Lean

Socket.dev; Newburyport (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

UFP Technologies, Inc. is seeking a Quality Engineer to provide technical support across Quality, Manufacturing and R&D in a cGMP and GDP environment, ensuring conformity to ISO 9001, ISO 13485 and AS9100.

The role includes investigation of nonconformances, CAPA, process control, and product launch support at UFPT and customer sites. On-site full-time in Newburyport, MA, with responsibilities spanning supplier qualification, metrology, calibration, and QMS audits to drive quality improvements

Qualifications

• Bachelor’s degree in Quality Assurance, Engineering, or Technology, plus 5 years of quality or manufacturing experience in regulated industry.
• CQE certification; 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.

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.

Skills

Quality Assurance

Statistical analysis

cGMP compliance

Cleanroom

GD&T

Education

Bachelor’s degree in QA/Engineering/Technology

CQE certification

Job description

UFP Technologies, Inc. is seeking a Quality Engineer to provide technical support across Quality, Manufacturing and R&D in a cGMP and GDP environment, ensuring conformity to ISO 9001, ISO 13485 and AS9100.

The role includes investigation of nonconformances, CAPA, process control, and product launch support at UFPT and customer sites. On-site full-time in Newburyport, MA, with responsibilities spanning supplier qualification, metrology, calibration, and QMS audits to drive quality improvements