Senior Quality Engineer, Medical Devices & Implants

Katalyst-Healthcares-; Olympia (WA); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in Olympia, WA seeks a Quality Engineer with 5+ years in medical devices, focusing on quality, validation and manufacturing engineering for surgical products.

You will lead process validation, PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, supplier qualification, and ensure GMP/ISO 13485 and FDA compliance while driving continuous improvement.

Qualifications

• 5+ years in Quality/Validation/Manufacturing Eng in medical products.
• Experience with IQ/OQ/PQ, PFMEA, Gage R&R, SPC, DOE, risk assessments.
• Surgical products and implants experience; GMP/ISO 13485/FDA knowledge.

Responsibilities

• Regulatory quality engineering and process validation tasks.
• Support manufacturing operations and problem-solving to drive improvements.
• Lead PFMEA/DFMEA, Gage R&R, TMV, Risk Assessments and Control Plan.
• Analyze data to drive decisions and continuous improvement; collaborate across teams.

Skills

Analytical skills

Problem solving

Cross-functional teamwork

Communication skills

Education

Bachelor in Mechanical Engineering

Tools

Minitab

Excel

Job description

Job Description:
Quality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.
Roles & Responsibilities:

• Experience in a GMP and/or ISO regulated medical industry is required.
• Ability to analyze and present data that facilitates & drives decision making is required.
• The ability to perform "hands on " troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.
• Experience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred
• Technical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.
• Ability to read and interpret CMM and dimensional inspection reports.
• Experience with dimensional data analysis utilizing software (Excel or Minitab)
• Experience in Medical Standards and Quality process preferred.
• New product launch experience from through full validation and commercial launch
• Experience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.
• Strong communication skills and ability to work well within a multidisciplinary team.
• Proficient with GD&T and interpreting technical drawings.
• Green or Black Belt Six Sigma certification preferred.

Requirements:

• Process Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R)
• Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab)
• Medical Device Quality Systems (GMP, ISO 13485, FDA Compliance)
• Bachelor in Mechanical Engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required.
• Required medical domain experience. Surgical Product and Implants experience preferred.