Senior Medical Device Engineer

JOB DESCRIPTION

The Sr. Medical Device Quality Engineer serves as a technical leader as a cornerstone of our quality operations; you will drive compliance and continuous improvement across the filtration device product lines. Ensure our QMS and manufacturing processes meet the highest standards while leading cross-functional and intercompany teams to resolve complex quality challenges.

Primary Responsibilities Regulatory Compliance:

Safeguard product integrity and process compliance in strict accordance with

FDA 21 CFR

Part 820 and

ISO 13485

standards. Ensure our QMS system meets customer requirements striving towards meeting medical device standards. (Not currently

ISO13485

)

Quality Management:

Direct the maintenance of internal QMS procedures and documentation to ensure audit readiness at all times. Serve as a key technical representative during internal and external regulatory audits.

Root Cause Analysis:

Lead technical investigations into product and process non-conformances using advanced methodologies (8D, Fishbone, 5-Why).

Customer Advocacy:

Direct data-driven technical discussions with customers regarding device performance and quality metrics.

CAPA Management:

Initiate and manage the CAPA lifecycle to mitigate risks and prevent recurrence of systemic quality issues.

Risk Management:

Execute and maintain PFMEAs on existing manufacturing processes to identify and reduce failure modes.

Cross-Functional Collaboration:

Partner with R D, Production and Engineering to develop, refine, and scale new manufacturing equipment and processes.

Secondary Responsibilities Supplier Quality:

Oversee supplier performance, qualifications, and the incoming inspection of critical medical-grade sub-components.

Automation Support:

Collaborate with Automation Engineering to integrate quality controls into automated manufacturing systems. Validation (V&V): Participate and provide technical oversight for process validation activities, including IQ, OQ, and PQ protocols and reports.

Records Maintenance:

Manage the lifecycle of quality records, including deviations, change controls, and investigation reports.

Post-Market Surveillance:

Assist in the evaluation of product complaints and field performance data.

Qualifications & Requirements Education:

Bachelor's degree in engineering or a related technical discipline.

Experience:

5-7 years of Quality Engineering experience within a regulated (Medical Device/Pharma) environment.

Certifications:

Six Sigma Green or Black Belt certification preferred.

Soft Skills:

Advanced project management skills with the ability to influence cross-functional teams (Supply Chain, Regulatory, Manufacturing). Preferred Skills ("The Plus Factor")

Advanced Certifications:

ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) .

Specialized Software:

Data Analysis:

Expert proficiency in Minitab , JMP , or SAS for advanced statistical analysis and process capability studies.

QMS Platforms:

Direct experience with enterprise Quality Management Systems such as Master Control , Greenlight Guru , Qualio , or ETQ Reliance .

Technical Expertise:

Familiarity with Computer-Aided Design (CAD) tools like SolidWorks to understand design intent and manufacturability. Experience with Risk Management Standards such as

ISO 14971

Physical Requirements Able to stand on production line to observe and implement processes. Able to utilize hand tools for inspection purposes. work environment Combination of office/cubicle and production floor