Quality Engineer – Manufacturing

Dielectrics, a UFP Technologies company; Newburyport (MA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life, and Dis

401K with matching contributions

Paid time off and holidays

Job summary

UFP Technologies, Inc. in Newburyport, MA, is hiring a Quality Engineer - Manufacturing to provide technical support across quality, manufacturing and R&D, ensuring compliance with cGMP, ISO 9001, and ISO 13485.

The role emphasizes problem solving, process improvement and data-driven decision making in a regulated setting. The position requires a bachelor's degree in quality/engineering, CQE certification, and experience with ISO13485/21 CFR Part 820; cleanroom and GD&T proficiency are highly

Qualifications

• Bachelor’s degree in Quality Assurance, Engineering, or Technology with 5 years of quality/manufacturing in regulated industry.
• CQE certification; additional 10 years of experience considered.
• Experience in ISO 13485 and 21 CFR Part 820 required.
• ISO 9001 or AS 9100 preferred.
• Thorough understanding of statistical process control and process capability.
• Cleanroom experience is required.
• GD&T certification is preferred.
• cGMP experience is preferred.

Responsibilities

• Upholds 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.
• Supports product development and production transfer activities.

Skills

Statistical process control

GD&T

Process capability

Quality improvement

Education

Bachelor’s degree in Quality Assurance, Engineering, or Technology

CQE certification

Job description

Quality Engineer - Manufacturing

Full-TimeQuality Assurance

Newburyport, MA, US

Salary Range: $85,000.00 To $110,000.00 Annually

About UFP MedTech

UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and 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

• Medical, Dental, Vision, Life, Disability Insurance
• 401K with a matching contribution
• Paid time off, Paid holidays, Employee discounts and much more!

Location

This position will be on-site full-time in Newburyport, MA.

Applicants must be authorized to work for any employer in the U.S. At this time, we are unable to sponsor or assume sponsorship of an employment visa.

Summary

The Quality Engineer provides 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. This position will support process and planning decisions with knowledge and explanations of Quality Engineering policies, practices, and procedures.

Duties and 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.

Qualifications

• 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.

UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled.