Provide product quality, design assurance and expertise to product development projects. Provide risk management throughout entire product lifecycle and assure compliance to the design control system. Lead cross functional projects; assure activities are completed within prescribed schedules and efficiently utilize resources. Identify areas of improvement, and either lead the necessary activities to completion or participate as an active member providing guidance to the team.
Provide hands-on technical quality engineering support for new product transitions internally and externally into production including development of quality requirements/plans for new products, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing.
Product Quality Engineering:
Provide quality support for manufacturing, inspection & test activities.
Lead product complaint investigation, analysis and final report creation.
Conduct statistical analysis of product for the identification of trends and coordinates the implementation of necessary corrective actions.
Review and approve document change orders (DCRs).
Generate inspection procedures for incoming parts and on-site production.
Develop test methods for new specifications and/or equipment.
Perform gauge R&R studies on test methods to assess capability.
Generate process Failure Mode Effect Analysis (FMEA).
Write protocols, perform testing, and write reports for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
Evaluate new equipment and fixtures and determine their impact on validation.
Support supplier qualifications and ongoing monitoring.
Support activities aimed at obtaining and maintaining QSR & ISO compliance.
Generate metrics for monitoring processes and quality system effectiveness
Participate in internal audits.
Participate in the Material Review Board (MRB), reviewing and approving material disposition.
Initiate, investigate and implement corrective and preventive actions (CAPA).
Provide quality system training.
Bachelor's degree in engineering
3 years of industry experience as quality engineer
2+ years of experience in medical device
2+ years experience with ISO 13485, FDA, and MDD
1+ years experience supporting manufacturing or new product development
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.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.