Quality Engineer – Medical Device CAPA & Process Improvement

Viant; Brimfield (MA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Full Medical, Dental & Vision

401(k)

Paid time off

On-Demand Pay

Job summary

Viant in Massachusetts is seeking a Quality Engineer to support Operations and ensure compliance with QMS/EMS and FDA requirements for medical device manufacturing.

You will review changes, lead CAPA and risk analyses, coordinate validations, and work with suppliers and internal teams to sustain product quality. 2–5 years of regulated manufacturing experience and a Bachelor’s in Engineering are required.

Qualifications

• Bachelor’s Degree in Engineering or related field required or 2–5 years of experience working in a quality engineering role within a regulated industry.
• 2-5 years’ experience in medical device or regulated manufacturing
• Strong communication skills and ability to align with key stakeholders
• Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016; MDSAP; ISO14971, QSR, MDD, TGA etc.)

Responsibilities

• Adheres to Quality Management Systems (QMS) and Environmental Management Systems (EMS) and applicable regulatory requirements.
• Supports regulatory inspections, audits, investigations, and inquiries regarding control and assessment of product design and manufacturing quality.
• Monitors manufacturing of assigned products, assuring compliance with DMR and maintaining Device History Records.
• Leads and implements product and process improvement methodologies.
• Reviews changes to BOMs, assembly procedures, drawings, specs, FMEAs, control plans, etc.
• Leads risk analysis and completion of protocols and reports for test method validations.
• Interfaces with Manufacturing Engineers to review processes, coordinate validations and capability studies.
• Develops inspection techniques and procedures to ensure product integrity and approval of inspection procedures.
• Ensures disposition of non-conforming materials meets regulatory requirements and corrective actions are taken.
• Communicates with customers and leads complaint investigations.
• Acts as lead in plant CAPA activities including data/trends analysis and root-cause analysis.
• Assists with product transfers and works with suppliers and teams to resolve quality problems.
• Coordinates quality plans for new product introductions and may supervise Inspectors/Technicians.

Skills

Quality engineering

Communication skills

Regulatory compliance

Problem solving

Education

Bachelor’s Degree in Engineering or related field

Tools

Microsoft Office

Minitab

Job description

Viant in Massachusetts is seeking a Quality Engineer to support Operations and ensure compliance with QMS/EMS and FDA requirements for medical device manufacturing.

You will review changes, lead CAPA and risk analyses, coordinate validations, and work with suppliers and internal teams to sustain product quality. 2–5 years of regulated manufacturing experience and a Bachelor’s in Engineering are required.