Find & Apply For Quality Inspector / Technician Jobs in Sturtevant, Wisconsin

Quality Investigator Job Type:

Contract Pay Rate:

$25/hour

Location:

Sturtevant, WI 53177 Job Summary We are seeking a Quality Investigator to support quality, manufacturing, engineering, R D, sustaining engineering, and New Product Introduction (NPI) activities. The ideal candidate will have experience in quality systems, investigations, change control, risk management, validation, and regulatory compliance within a medical device or regulated manufacturing environment . This role will work cross-functionally to ensure product and process changes meet quality and regulatory requirements while supporting continuous improvement initiatives. Key ResponsibilitiesDesign Control Support Operations, Sustaining Engineering, R D, and NPI teams in the development, verification, and validation of product changes and new product introductions. Review and support design-related quality activities to ensure compliance with applicable procedures and regulations. Originate and review internal operating procedures and specifications through the Document Change process. Risk Management Support Risk Management activities, including the review and coordination of quality-related risk activities. Assist with maintaining and updating risk management documentation as required. Change Control Support Change Control activities across Operations, Engineering, Design, and other functional areas. Coordinate updates to operating procedures, processes, products, specifications, and risk management files through the established Change Control process. Support the implementation and documentation of approved changes. Validation & Qualification Support equipment and process validation and qualification activities, including IQ, OQ, and PQ . Assist with validation activities associated with equipment, processes, and product updates through the Change Control process. Quality Improvement Identify and support quality improvement initiatives in accordance with cGMP and quality system requirements . Develop and support projects focused on reducing defects, improving compliance, increasing quality levels, and improving operational efficiency. Lead process improvement initiatives within the Quality Department. Analyze quality data to identify trends, recurring issues, and opportunities for improvement.

NCR & CAPA

Support Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs) . Execute corrective and preventive actions related to product non-conformances and quality issues. Conduct and document investigations associated with product deviations, non-conformances, CAPAs, scrap, and rework. Collect, analyze, and report quality data to support root-cause identification and continuous improvement. Manufacturing & Regulatory Compliance Work closely with Manufacturing and other functional teams to address regulatory and quality system issues. Ensure activities comply with applicable Federal, State, and Local regulations governing the manufacture of medical devices. Support regulatory inspections involving federal, state, and local regulatory officials. Support internal and supplier/vendor quality system audits as applicable. Training Support the Quality training program by delivering assigned training and assisting with training-related activities. Promote awareness and adherence to quality procedures and regulatory requirements. Additional Responsibilities Provide support to Quality Management personnel as needed. Participate in cross-functional quality initiatives and projects. Perform other duties and responsibilities as assigned. Qualifications Experience in Quality Assurance, Quality Engineering, Quality Investigation, or a related field , preferably within medical devices or regulated manufacturing. Knowledge of cGMP, quality systems, and regulatory requirements . Experience with NCR, CAPA, Change Control, Risk Management, and investigations preferred. Familiarity with

IQ/OQ/PQ

validation and qualification activities . Strong analytical, problem-solving, and documentation skills. Ability to work effectively with cross-functional teams. Strong written and verbal communication skills. Ability to manage multiple priorities in a fast-paced manufacturing environment. Strong attention to detail and commitment to quality and compliance. Preferred Experience Medical device manufacturing FDA-regulated manufacturing environments Quality investigations and root-cause analysis CAPA and non-conformance management Change control and document control Risk management Process and equipment validation Internal and supplier quality audits Continuous improvement / process improvement

Compensation Pay Rate:

$25/hour This job description provides an overview of the general nature and level of work associated with this position. It is not intended to be an exhaustive list of all responsibilities, duties, qualifications, or skills required. Additional duties may be assigned based on business needs.

Pay:

$25.00 per hour

Benefits:

401(k) Dental insurance

Work Location:

In person