Sr Quality Engineer - Exempt

LanceSoft Inc

Lafayette, CO

Apply

JOB DETAILS

JOB TYPE

Full-time

SKILLS

Auditing, Calibration, Certified Ambulatory Perianesthesia Nurse (CAPA), Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Collection, Design Services, Equipment Validation, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Functional Configuration Audit (FCA), Injection Molding, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Equipment, Patient Safety, Performance Analysis, Performance Reviews, Problem Solving Skills, Process Capability, Product Design, Product Management, Product Reviews, Product Safety, Project Management Professional (PMP), Project/Program Management, Quality Assurance Methodology, Quality Engineering, Quality Metrics, RPM, Regulatory Compliance, Regulatory Reports, Regulatory Requirements, Reporting Skills, Risk Analysis, Risk Management, Six Sigma Certification, Standard Operating Procedures (SOP), Training Program, Trend Analysis, Validation Testing, Welding

LOCATION

Lafayette, CO

POSTED

30+ days ago

The Senior Quality Engineer will be responsible for providing quality engineering oversight for design changes to released medical devices, ensuring continued compliance with applicable regulatory requirements and internal standards. While this role does not support day-to-day manufacturing operations, a strong understanding of manufacturing processes (e.g., injection molding, ultrasonic welding, etc.) is essential for evaluating the impact of design changes on product quality and process capability. Responsibilities Represent the Released Product Management (RPM) Design Quality team on projects addressing day-to-day quality issues of market-released products. Ensure compliance with RPM activities per applicable Standard Operating Procedures (SOPs) and External Standards. Contribute to and lead activities including risk analysis, product risk assessment, Failure Mode and Effects Analysis, and assessing specific product issues for impact on patient and user safety and product quality. Conduct drawing and specification reviews, verification and validation testing and reporting, product performance reviews, and test method validation. Perform DHF audits and mechanical drawing review and approval per ASTM-14.5Y. Engage in technical problem-solving, compile data, prepare reports on findings to identify trends, and propose corrective action as needed. Collaborate with RPM project cross-functional teams to ensure quality standards are in place. Specialize in RPM risk management, test method validation, and equipment calibration/qualification/validation. Must Have CAPA Medical Device Risk Management RPM Quality Nice to Have 10 Years design experience in the medical device industry, Class III experience helpful, but not required Kaizen Lean Six Sigma Certified Experience in Complaint Handling, Regulatory Reporting, FCA, FDA, and/or CAPA PMP Certification or other formal Project Management training and experience Program Management/Project Management Top 3 Technical Skills Required Manufacturing experience Medical device risk management Compliance effective oversight Education and Experience Bachelor’s Degree in Engineering, Science, or a technical field with a minimum of 6 years of work experience in Engineering and/or Quality. Work Hours and Location 40 hours/week, onsite. Interview Timeline As soon as possible, this is an urgent hire. Product Line Support Navigation Systems within ET/CST.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Resume Resources

Free Resume Templates Free Resume Builder