Lucas Group has partnered with a medical device manufacturer seeking to hire a Quality Auditor to support their production manufacturing teams. He/she will be responsible for ensuring daily production activities adhere to specified bill of materials (BOM), work instructions, and quality standards for each product line. Plans, executes and prepares clear and concise written reports of audit or review observations, including an assessment of compliance during internal audits of facility quality systems.
- Ensures Manufacturing compliance to cGMP & cGDP requirements and alerts supervisors when issues are identified
- Responsible for reviewing and auditing activities of the workers and supervisors on the production lines and warehouse including receiving & shipping
- Plans and directs the auditing activities for stated operational departments.
- Review and audit BOMs, work instructions, production components/items, and employee activities to ensure they all adhere to established standards.
- Correct documentation as it relates to BOMs, work instructions, production components/items.
- Perform periodic final inspections at each production cell to ensure product quality is aligned with company standards.
- Escalates audit findings to the appropriate level of management.
- Ensures Manufacturing compliance to cGMP & cGDP requirements and alerts supervisors when issues are identifies
- Promotes improvement through problem solving techniques, 5S and other lean manufacturing processes.
- Associates/Bachelor’s degree in Engineering or Scientific field or equivalent preferred.
- Candidate must have several years of creating audit plans, performing audits, writing audit reports, and following up with internal staff to ensure audit findings are being addressed by process owners.
- ISO and/or ASQ-CQA (Certified Quality Auditor) desired.
- Ability to prioritize and multi-task successfully in a fast-paced environment
- Ability to work both independently and in a collaborative team setting.