Quality Investigator INT#26-03462

Franksville, WI

Onsite Job Description

Design Control

• Support operations, sustaining engineering, R D and NPI departments in the development, verification and validation of product changes and introduction of new products. Originate and review internal operating procedures and specifications through the Document Change process Risk Management
• Support Risk Management activities including review and coordination of quality activities related to risk. Change Control
• Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to operating procedures, process, product / specifications, risk management files, etc through the Change Control process. Support validation and qualification activities (IQ-OQ-PQ) of equipment and process updates through the Change Control Process. Quality initiatives
• Identify new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies Works with manufacturing and other functional groups on manufacturing regulatory compliance issue Support training program by delivering assigned training tasks Leads process improvement initiatives for the Quality Department Support Client and CAPA Execute corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.

Adherence to regulations Ensures adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices. Inspections

• Support with federal, state, and local regulatory officials during regulatory inspections Support in internal and vendor quality system audits as applicable Other duties as assigned Provides support to Quality Management personnel and perform other duties as assigned This job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job.

The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time.