Duties/Responsibilities include but are not limited to:

• Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner.
• Meets commitments on time with accuracy and attention to detail.
• Maintains current knowledge base of applicable medical device regulations (FDA QSR, ISO 13485, ISO14971) and other associated standards or guidance documents.
• Based on assignment, will perform the following activities:
• Set-up, adjust, align, and run complex inspection equipment including Coordinate measuring machines (CMM).
• Conduct component first piece, and assembly inspections per inspection documentation which includes visual and dimensional inspections using standards and inspection tools
• Collect and analyze data using software programs
• Calibrate equipment
• Identify, create and triage nonconformances and document in Epicor according to company procedures
• Perform evaluation of returned goods
• Creates and runs CMM programs
• Performs inspection per documented inspection plans and test methods.
• Develops control plans and inspection methods from estimates, engineering drawings and other specifications to determine acceptance and rejection criteria
• Supports failure investigations
• Participates in continuous improvement and Lean initiatives
• Performs other related duties as assigned by management.
• Participates in the development and conduct of training for visual and dimensional inspections. Supports other Quality training as assigned.
• Assists with equipment and method qualifications

Training/Education/Experience:

• High school diploma required
• Technical program certification (e.g. ASQ-CQT) or Associates Degree in Quality Technology preferred
• Proficient with Microsoft office software, especially Excel and Word. Computer skilled and able to learn Quality Software Systems including Epicor and Master Control.
• Ability to read and interpret basic to moderately complex engineering drawings and specifications
• Familiarity with inspection tools including CMM type equipment
• Understanding of GD&T principles
• At least 2-years' experience as a QTII, or Associates Degree in related field, an at least 2-years' experience in a manufacturing environment including knowledge of CMM programming

Physical Requirements:

• Vision correctable to 20/20 with normal color vision (where inspection criteria requires color discernment)
• Technical aptitude to work with equipment and inspection tools including but not limited to calipers, microscopes, and CMM type equipment
• Regularly required to sit as well as climb or balance, stoop, kneel and crouch.
• Must be able to work in manufacturing environments exposed to moving mechanical parts and restricted gowning requirements.
• Must occasionally lift and/or move up to 25 pounds.

Competencies/Talents/Personal Attributes

• Well-developed written and verbal communication skills in English. Ability to effectively present information to all levels within the organization, regulators, and customers
• Results oriented, self-starter, who can simultaneously work independently and as a high-performance-team member
• Strong attention to detail
• Very organized and able to maintain organized records
• Proficient with Microsoft Office software and familiar with CMM program execution and programming and GD&T software (SmartProfile, Measure-Fit)
• Able to create graphs and tabulate data
• Ability to prioritize and drive multiple activities and adapt to changing business needs;
• High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal supervision.
• Able to explain complex/technical matters;
• Technical aptitude to work with equipment and tools including measurement equipment such as calipers, microscopes, and test equipment.

Job Type: Full-time

Salary: $23.78 - $37.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Medical device Quality Technician: 1 year (Required)
• Coordinate measuring machines (CMM): 1 year (Required)
• GD&T: 1 year (Required)
• Calipers, microscopes, and CMM type equipment: 1 year (Required)

License/Certification:

• ASQ-CQT (Required)

Ability to Relocate:

• Saint Paul, MN 55101: Relocate before starting work (Required)

Work Location: In person