The Quality Engineer II will support the manufacturing of medical devices. This individual will with work Product Development, Service and Manufacturing to resolve product quality issues. The Quality Engineer II will also support manufacturing process changes, continuous improvement initiatives and establishing/meeting in-process performance metrics. 

Primary responsibilities include working in Quality Operations, Quality Engineering and with other functional groups in support of day-to-day activities relating to legacy products.

• Calibration Management utilizing Maximo Software
• Nonconformance Management utilizing Trackwise.
• Reviewing Incoming Inspection Records, Travelers and DHR’s for the acceptance of raw materials, WIP and Finished goods.
• Review and revise quality control plans
• Execute equipment qualifications (gage R&R studies, etc., document change orders.
• Develop and manage metrology equipment requirements, maintenance, and validation.
• Provides technical assistance/oversight in defining and conducting both internal and external product and process audits, working closely with Quality Operations, Product Development, and Manufacturing personnel as well as vendors.
• Ensure compliance with all Federal, State, local and company regulations, policies, and procedures.
• Performs other quality-related duties as assigned by supervisor.
• Initiate and investigate component, process, and Product NCRs
• Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
• Assist in complaint analysis as appropriate.
• Train, coach, and guide lower-level employees on routine procedures.
• Initiate and investigate component, process, and Product NCRs
• Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
• Assist in complaint analysis as appropriate.
• Train, coach, and guide lower-level employees on routine procedures.
• Develop trend requirements to support the QA/QC department in the following areas: NCR, CAPA, and SPC processes for incoming inspection, process, and vendor operations.
• Performs other duties assigned as needed.

• Bachelor’s Degree in a technical field, preferably engineering or life sciences   
• 3-7 years of quality engineering experience in a regulated industry (medical device, pharmaceutical, aerospace, automotive)
• Knowledge, Skills, and Abilities
• Strong knowledge of medical device manufacturing
• Working understanding of GMP and ISO 13845 requirements
• A work style of hands-on involvement with all phases of projects
• Experience performing in-process assembly and manufacturing verification inspections desirable
• Excellent documentation skills with attention to detail and accuracy
• Team player, good written/oral communicator
• Must be organized and able to coordinate activities with internal departments and outside vendors