Sr Associate, Quality Assurance

Required Skills & Experience

• Bachelor's degree in engineering or science.
• Minimum 5 years of experience in regulated Quality Assurance, Document Control, or Configuration Control, or a formal education equivalent.
• Ability to work independently, multi-task, and thrive in a fast-paced environment.
• Excellent written and verbal communication skills.
• Proficiency with Windows OS and Microsoft Office Suite, including Word, Excel, and PowerPoint.
• Proven knowledge and understanding of FDA 21 CFR 820 and ISO 13485.
• Familiarity with root cause analysis tools.
• Working knowledge of MasterControl and SAP.
• Ability to support and contribute to Lean Sigma programs and activities.
• Ability to make and implement decisions based on experience and facts and provide direction to peers or less experienced team members.
• Ability to understand and remain aware of relevant SOPs, Company Policy, and the Quality Manual.
• Ability to comply with company safety policies at all times.

Nice to Have Skills & Experience

• Master's Degree in Engineering or Science.
• Experience with Medical Device Product Development Life Cycle activities.
• Experience with Verification and Validation activities.
• Experience with Risk Management.
• Experience with DHF activities.
• Experience working with quality systems including:

○ ISO 9001

○ ISO 15378

○ ISO 13485

○ 21 CFR 820

• Experience leading internal and external audits.
• Experience with MasterControl, SAP, and SharePoint.
• Experience interfacing directly with customers and meeting customer expectations. Proficiency with statistical software.

Job Description

Our client is seeking a Sr Associate, Quality Assurance to oversee quality projects, maintain quality processes, and address quality issues through data analysis, investigation, and cross-functional collaboration.

This position will support routine Quality Assurance activities within an active WSS laboratory environment as well as QA responsibilities associated with future business. The role will be responsible for quality systems, customer complaints, investigations, audits, documentation review, CAPA activities, continuous improvement, and customer communication.

This is a fully onsite position.