The Inspector will be expected to work closely with members of the Quality team to:- Perform required inspection of incoming materials per standard operating procedures,- Perform in-process inspections per standard operating procedures,- Perform shipping audits per standard operating procedures,- Be the primary communicator with other departments to resolve issues or gaps in inspection criteria or instructions,- Generate Nonconformance reports to record and control failures from inspection activities.- Perform other inspections, audits, and duties as needed- Complete DHR audits to ensure released products are built according to released specifications- Complete verification checks for product and documentation from Nonconforming rework- Provide feedback to improve inspection plans based upon gaps identified
1-4 years
- An AA degree in a technical field or 1-3 years' experience in inspection/quality related work in the medical device or other regulated field- 1-5 years' experience in a manufacturing environment- Able to understand and follow component specifications, purchase and assembly drawings, test procedures, sampling plans and written instructions- Naturally curious and with strong ability to identify and resolve problems- Above average written and oral communication- Able to effectively and independently prioritize assignments & manage workload- Experience with Microsoft Office Suite- Must maintain a quality first mindset and be process oriented.- Verbal and written communication must be appropriate for an audit.- Update and refine processes, procedures, and forms, practicing lean principles and implementing 6S.- Identify improvement opportunities and participate in Kaizen events.- Active participant in QMS activities including complaint investigation, CAPA and regulatory compliance.- Must be detail oriented.
- Experience with a medical device company is a plus
Associate
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