Posting ID: JP-002024083
Design and implement inspection methods, and equipment Initiate or assist in cost reductions of product inspections Ensure effective design control and transfer to production Provide validation, sampling, and statistical analysis support to other functions in the organization Lead Quality issue resolution by applying root cause methodologies Perform First Article Inspections to ensure Manufacturing process capability Lead quality planning activities for new product development projects, to include verification and validation plans
Pharmaceutical, Bio Med, Quality, Pharma, Medical Device, Manufacturing, GD T, QMS, ASQ, Six Sigma, tissue, tissue processing, nerve, validation, cGMP, GMP, Regulatory, Ppap, Quality management, Capa, Audit, root cause analysis, Commissioning, Manufacturing engineering, Process engineering, Process improvement, CFR Part
Top Skills Details:
MUSTS - 3+ years of engineering experience in Medical Device, Pharma, Tissue or Bio-Medical Environment - 3+ years of Quality and/or Manufacturing Engineering experience - 3+ years Root Cause Methodology - Experience working with suppliers to design inspection / quality systems and resolve issues - Quality System regulations and requirements (ie 21 CFR part 820, CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971) - cGMP knowledge and understanding
Additional Skills & Qualifications:
EDUCATION - Biomedical Engineering Degree is great! - Traditional Engineering degree works as well NICE TO HAVE - ASQ Certification - Lead Auditor Certified - Six Sigma Black Belt DISQUALIFIERS - Any currents at Community Tissue Services or Community Blood Center - Any currents at Lifenet in VA Beach BEST V AVG The best candidate has worked in a Tissue Processing environment and has experience with the set-up of a new or relocated manufacturing facility
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Phillip Chin