Quality Inspector

Job Description

Job Description

Resolve Surgical Technologies is looking for a part-time, 2nd shift or weekend shift Quality Inspector to join our team!

Great opportunity for anyone looking for a flexible schedule or college attendees looking for employment around their class schedule.

Shift preference is on 2nd shift between the hours of 3:00pm-11:30pm (Monday-Friday)

or Weekend shift between the hours of 6:00am-6:30pm (Friday-Sunday)

Resolve Surgical Technologies is a global, world-class CDMO+ that provides new product design, development, manufacturing, quality, and regulatory services in support of leading medical technology companies. Located near Lake Superior, in beautiful Marquette, Michigan, this "must-see" travel destination is truly an outdoor paradise, teeming with natural beauty year-round. With a community that is as beautiful as its shorelines, Marquette is an up and coming city that welcomes all styles of outdoor enthusiasts.

The Quality Inspector: involves inspection of products made in-house and supplier purchased products. The product is inspected through various high precision measurement equipment. It involves reading, understanding, and following work policies and procedures while working in a team environment. This position will help Resolve Surgical maximize the amount of patients served while maintaining a high level of quality and safety.

Shift Options - (may vary depending on availability)

• 2nd shift (4pm-2:30am)
• Weekend

POSITION SUMMARY:

• Support production operations working to achieve optimal product quality.
• Perform investigations for product nonconformance(s)/process noncompliance issues and document exception in the CAPA system appropriately.
• Assist in performing, documenting, and training personnel for proper use of quality equipment in production.
• Operate inspection equipment including but not limited to Vision Systems, CMM, profilometer, etc.
• Perform inspection activities for both purchased and in-house manufactured semi-finished and finished goods for conformance to specification, drawing, and inspection requirements using various visual, physical, mechanical, and/or electrical evaluations.
• Perform product acceptance testing, quality inspections, and data entry/data corrections.
• Accurately document results of inspections and testing, including nonconformance reporting when required.
• Perform review of documentation for compliance to established procedures and GDP.
• Ensure all non-compliance issues associated with inspections are accurately reported.
• Perform routine AQL inspections and conduct 100% inspections as required.
• Sample, analyze, and monitor product quality in accordance with established procedures.
• Effectively communicate issues to Quality Engineering and/or operations.
• Perform documentation activities that adhere to cGMP and GDP.
• Utilize various measurement tools and instruments such as calipers, scales, thickness gauges, force gauges, optical comparator, various hard gages, pipets, and other systems.
• Perform inspection activities of printed materials against master documents for differences.
• Update release status of materials electronically to indicate acceptance or rejection, and communicate status to various departments.
• Perform programming of inspection equipment (i.e. Vision Systems and Digital Comparators).
• Support Gage R&R's
• Conduct Bioburden Endotoxin Testing

*This is not an exhaustive list of duties or functions and may not necessarily comprise all the essential functions*

EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED: (list required and preferred separately)

Quality Inspector I:

• High School diploma or equivalent required
• One year experience in medical device or Quality Control environment preferred
• 6+ months of relevant coursework preferred

KNOWLEDGE, SKILLS, AND ABILITIES: 

Technical Competencies

• Basic computer skills (following standard operations procedures, navigating One Drive/Sharepoint)
• Basic math and print reading
• Fundamental or basic understanding of Geometric Dimensioning and Tolerancing (GD&T)
• Ability to perform basic inspections techniques
• Basic understanding of Propel
• Ability to locate priority orders and check their status through SAP

Behavioral & Basic Skill Competencies

• Team player with ability to work cooperatively with others 
• Positive attitude
• Strong active listening skills and the ability to follow directions, learn, and adapt
• Effective verbal and written communication skills with various departments
• Work ethic and punctuality (follow work schedule, work full duration of shift, and work overtime as needed)
• Attention to detail 
• Mechanical aptitude 
• Problem-solving and critical thinking skills 
• Ability to multi-task 
• Strong demonstration of Resolve’s Values, Mission, and Vision
• Safety and Quality mindset

This position requires the use of personal protective equipment during various tasks/activities including but not limited to scrubs, gloves, masks, safety glasses, and safety shoes.