Big Lake Township, Minnesota, United States · On-site
$100k–$120k/yr
Senior
Join our growing team in Big Lake, MN! Reporting to the Quality Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision m…
Skills: Team Leadership, Quality Control, ISO 13485, Blueprint Reading, Dimensional Inspection
Summary of Position: This strategic leadership role is responsible for the overall direction and execution of Human Resources and Organizational Development programs across all company facilities. This includes developin…
SUMMARY OF POSITION: Reporting to the Department Manager, this position is primarily responsible for working in a functional Scheduling and Planning group. Working with a combination of firm orders, customer forecasts, a…
Big Lake Township, Minnesota, United States · On-site
$80k–$110k/yr
Mid level
SUMMARY OF POSITION: This position will be responsible for the activities associated with Quality Sustained Manufacturing of commercial product and successful transfer of Development programs to standard production. This…
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$100k–$120k/yr
Full-time
high school, professional certificate
Posted 7d ago
~40 hrs/week
Responsibilities
Supervise quality inspection and packaging personnel to ensure adherence to ISO 13485 standards and quality manuals. Perform technical inspections on machined components and manage Device History Records for final lot release.
Requirements
Requires a minimum of 7 years of experience in a regulated manufacturing environment and a high school diploma or equivalent. Must be proficient in using mechanical measurement tools and reading technical blueprints.
Full job description
Join our growing team in Big Lake, MN! Reporting to the Quality Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to supervise inspectors and packaging personnel while maintaining the ISO 13485 standards, and the requirements of our Quality Manual.
Essential Functions:
Demonstrate team leadership, train, and provide guidance to Quality Control personnel.
Aligns and prioritizes workload. Creates targets and expectations for work performance.
Assist with hiring of new employees (interviews, on-boarding, training)
Coaches and corrects team as required, approves time sheets.
Drive continuous improvement through the departments with the Quality team.
Identify areas of improvement, and work with the Quality and Engineering teams to create a solution and implement the solution.
Provides input for and performance appraisals to employees.
Train and perform inspections on machined components and assemblies using visual and layout techniques and equipment, such as microscopes, calipers, micrometers, and gages.
Create, complete, and compile documentation related to Quality Inspection standards, ensuring proper material control, identification, and traceability throughout the manufacturing processes.
Ensure conformance to Quality standards by reviewing Device History Records (DHRs) and ensuring they align with the Device Master Record (DMR), and that Good Document Practices (GDP) are maintained for Routers, Inspection Plans, and DHRs during the manufacturing process and final lot release.
Utilize ERP and QMS systems to document inspection activities, ensure traceability, and maintain proper control of records.
Execute Incoming, In-process, and Final Inspections as assigned, recording nonconformities, ensuring follow-up actions, and moving materials into MRB if issues remain unaddressed.
Perform material sorts as needed, ensuring nonconformities are identified and addressed.
Adhere to safety protocols and PPE requirements in all tasks.
Adapt to different quality standards, production lines, and teams, and move between multiple departments and production lines as required with a proactive approach.
Additional responsibilities as outlined in the full job description.
Perform other duties as assigned.
Qualifications:
Ability to automatically pivot in a fast-paced work environment.
The ability to effectively manage inspection and packaging personnel.
The ability to effectively read and understand blueprints, specifications, and procedures.
Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
Knowledge of dimensional, visual, and mechanical inspection processes.
Competency with Microsoft Office.
Ability to work both independently and as part of a team.
Verbal and written English language communication skills.
Basic mathematical computational ability.
Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
Class I, II and/or III Medical Device manufacturing experience.
Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical, etc.)
Education:
High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience:
Minimum of 7 years’ experience in a regulated manufacturing environment or equivalent education and experience.
Knowledge of and experience with GMP/ISO standards.
Physical Requirements:
Ability to bend, stoop, squat, kneel, and lift to 50 pounds. Team lifts or mechanical assistance is required for objects over 50 pounds.
Exposure to oil, grease, dust, metal particles, sparks, and sharp-edged materials. Some exposures may require the use of personal protective equipment or engineering controls.
20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
Ability to sit or stand for prolonged periods.
Perform keyboard entries with possible frequent operation of a computer.
TOMZ is an Equal Opportunity Employer
Related keywords
ISO 13485Medical DevicesDHRDMRGDPERPQMSMRBASQ CQTQCIGMPMicrometersCalipersDial IndicatorsHeight GagesPin Gages
An industry leading manufacturer of life-changing medical devices and implants.
Industry
Medical Equipment Manufacturing
Company size
201-500 employees
Founded
1988
Headquarters
Berlin, CT
LinkedIn followers
8,225
ISO 13485:2016 Certified & FDA Registered
TOMZ Corporation was founded in 1988 and is a leader in the manufacturing of precision components for major medical device, healthcare and laboratory diagnostics. We have been able to maintain private ownership and operation since inception and will continue into the next generation.
With 200,000+ square feet, our facilities across Connecticut, Indiana and Minnesota house state of the art, validated CNC Lathe/Mill/Wire EDM, Finishing, Passivation/Anodize, Inspection, to Package & Label. We are truly your "one stop shop."
TOMZ understands and works closely with our customers to provide the best engineering services, product, for the best price, with the best delivery.
TOMZ Corporation is headquartered at 47 Episcopal Rd. Berlin, CT.
Offices: 47 Episcopal Rd, Berlin, CT 06037, US · 12 Municipal Dr, Fishers, Indiana 46038, US · 20033 176th St NW, Big Lake, Minnesota 55309, US
CNC TurningCNC MachiningAnodizingPassivationLaser MarkingPackagingBead BlastingGrit BlastingPackage and LabelPrototyping
An industry leading manufacturer of life-changing medical devices and implants.
Industry
Medical Equipment Manufacturing
Company size
201-500 employees
Founded
1988
Headquarters
Berlin, CT
LinkedIn followers
8,225
ISO 13485:2016 Certified & FDA Registered
TOMZ Corporation was founded in 1988 and is a leader in the manufacturing of precision components for major medical device, healthcare and laboratory diagnostics. We have been able to maintain private ownership and operation since inception and will continue into the next generation.
With 200,000+ square feet, our facilities across Connecticut, Indiana and Minnesota house state of the art, validated CNC Lathe/Mill/Wire EDM, Finishing, Passivation/Anodize, Inspection, to Package & Label. We are truly your "one stop shop."
TOMZ understands and works closely with our customers to provide the best engineering services, product, for the best price, with the best delivery.
TOMZ Corporation is headquartered at 47 Episcopal Rd. Berlin, CT.
Offices: 47 Episcopal Rd, Berlin, CT 06037, US · 12 Municipal Dr, Fishers, Indiana 46038, US · 20033 176th St NW, Big Lake, Minnesota 55309, US
CNC TurningCNC MachiningAnodizingPassivationLaser MarkingPackagingBead BlastingGrit BlastingPackage and LabelPrototyping