Piper Clinical Solutions is actively seeking a Senior Medical Device Quality/ Validation Engineer to work at a Medical Device and Pharmaceutical company in the Raleigh / Durham area.
Responsibilities for Senior Medical Device Quality/ Validation Engineer:
- Set up, Manage and act as Quality Representative overseeing the qualification-re-qualification program, design and development projects, validation, change control, annual product review.
- Participate in and oversee design reviews as well as provide technical expertise in product and process improvement identifying potential issues as well as corrective actions to minimize impact on budget, resources and project scope.
- Write up, review and revise method development as well as method transfer for all critical performance tests, qualification measurement system analysis (MSA's), Standard Operating Procedures (SOP's) design history files (DHF's) and Statistical Process Control (SPC's), Failure Modes and Effects Analysis (FMEA).
- Approve and execute Installation/Operation Qualifications (IOQ's) as well as oversee validation of devices, equipment and automation/controls.
- Participate in Process and Product evaluations to identify improvements
- Work with multiple departments including document control, research and development and manufacturing.
- Provide training and/ or supervision for contract validation and quality resources.
Requirements for Senior Medical Device Quality/ Validation Engineer:
- Minimum of Bachelor’s Degree in chemistry, biology, biochemistry, or related field.
- 8-10 years of regulated industry experience in a quality engineer role within a medical device company, biotech company, pharmaceutical company or related setting.
- Hands on experience with validation engineering, process engineering, and quality systems.
- Experience with medical devices and combination products.
- In-depth knowledge of 21 CFR Part4, Part 11, Parts 210/211, Part 820 is required.
- In-depth knowledge and understanding of design history files (DHF), combinations products, quality systems, validation principles, computer systems and strong engineering design fundamentals (CSV, GAMP5, V-Model, ASTM E2500).
- Certified Qualified Engineer (CQE) is preferred.
Compensation & Benefits for Senior Medical Device Quality/ Validation Engineer:
- Annual Salary $100k - $130k based on previous experience and industry background.
- Full Benefits: Medical, Dental, Vision and Life Insurance, Flexible Spending Accounts, Matching 401k, Short and Long Term Disability, Employee Assistance Program, PTO, Sick Days, etc.
Qualified candidates please send resumes to Wesley Garrett at WGarrett@Pipercompanies.com
Keywords: Quality Engineer, Combination Product, Medical Device, Standard Operating Procedure (SOP), Statistical Process Control (SPC), Installation, Operational, Performance, Qualification (IQ/OQ/PQ), Validation, Design History File (DHF), Quality Systems, Failure Modes Effects Analysis (FMEA), CQE, ASQ, CFR, GMP, cGMP, Regulated, Change Control, Product and Process Improvement, Corrective and Preventative Action (CAPA), Measurement System Analysis (MSA), Risk Mitigation, Raleigh, Durham, RTP, RDU, Wake Forest, Brier Creek, Knightdale, Garner, Clayton, Franklinton, Creedmoor, Cary, Morrisville, Burlington, Chapel Hill, Apex, Fuquay-Varina, Holly Springs, Smithfield, Dunn, Wilson, Henderson, Carrboro, North Carolina, NC