SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract Quality Engineer II to join our client's medical device manufacturing team in Columbia, MD. Responsible for maintaining critical management systems and assuring the efficacy of established process control programs, including calibration and maintenance, change management, validation, environmental monitoring, and others.

*THIS POSITION IS FOR A W2 CONTRACT ONLY, we cannot accept C2C.

MUST HAVES:

• 5+ years of experience in Quality Engineering or related roles
• Medical Device Experience
• Bachelor's degree required
• Certifications: American Society for Quality (ASQ) or Regulatory Affairs Professionals (RAPS) certificates or similar are preferred
• Technical specialization in change management and data integrity, systems development/validation, or data integration/trending

JOB RESPONSIBILITIES:

• Facilitate and maintain the change management system.
• Perform Quality Investigations
• Develop, review, and approve quality records, including SOPs, plans, protocols, and reports, supporting GxP manufacturing and development.
• Support the efficacy of critical control programs. E.g.- calibration and preventive maintenance, environmental monitoring, change management, etc.)
• Maintains a thorough understanding of the following: 21CFR820, ISO 13485, Regulation 2017/745 (EUMDR), the Canadian Medical Device Regulations (CMDR)

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.