Quality Investigator Jr

Job Description

Job Description

HCR0003281/2
Quality Investigator Jr
Pay Rate: 22-25/HR pn W2
Location: Sturtevant, WI 53177

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.

Kindly share your resume with answers: 
Q1: How many years of experience do you have in medical device Quality Engineering or Quality Systems ?
Q2: Please describe your hands-on experience with Design Control , including design changes, verification, validation, and new product introduction.
Q3: How far you live and how will you commute to Sturtevant, WI 53177