What are the responsibilities and job description for the Quality Manager position at In'Tech Industries, Inc?
We are looking for a Quality Manager to join our team. The ideal candidate will lead, direct, coordinate, and maintain activities associated with the Quality Function, ISO 13485 Medical Device Quality Management System, and FDA Quality System Regulations. This position includes responsibility for directing the quality function and developing quality policies, processes, and procedures, as well as process improvements and corrective/preventative actions that follow the company quality policy.
Essential Job Functions:
- Act as the Quality Management Representative overseeing the Quality Management System and conformance to the ISO 13485 and FDA quality requirements.
- Oversees the development, maintenance, and implementation of regulatory requirements such as ROHS and REACH.
- Oversees the Material Review Board (MRB) with personnel from quality, production, sales, and engineering about nonconforming product.
- Manages a team of quality personnel, providing direction, coaching, and support to optimize their performance.
- Assists in new product launches by participating in design reviews and risk assessments.
- Manages quality objectives by tracking and reporting, leading data-driven initiatives to address areas of improvement.
- Oversees and assists in the resolution, documentation, and responses for quality issues, customer complaints, or non-conformances.
- Manages the completion of corrective/preventative action processes to ensure effective documentation and systematic processes are implemented.
- Oversees the coordination efforts for external services such as calibration and product testing for quality purposes.
- Participates and coordinates all internal and external quality audits.
- Oversees quality assurance training to all levels of personnel in the organization.
- Oversees material certifications that ensure the quality and integrity of materials used in the company.
- Participates and collaborates with cross-functional teams to drive continuous improvement in manufacturing processes, reducing defects, and enhancing overall product quality.
Essential Job Qualifications:
- Must have prior quality management experience, a minimum of 5 years' experience in a quality management role.
- Must have experience with ISO 13485 or 9001
- Prefer experience with FDA conformance requirements as it relates to quality function and manufacturing.
- Preferred injection molding experience.
- Must have excellent time management skills understanding how to create and work to priorities, self-motivated.
- Must be able to motivate a team and direct reports to optimal performance.
About the Company:
In’Tech Industries enhances quality of life by designing and manufacturing high quality innovative products. In’Tech is an industry leader in Product Development and Quality Manufacturing solutions in 3-D Printing, Tooling, Engineering Services, and Injection Molding. The Company has been in business for 50 years as a tooling and manufacturing company specializing in plastic injection molds and the 3-D printing industry. We offer competitive wages and benefits in a fast paced, fun working environment where employees are valued and respected. In’Tech is privately owned in Ramsey, MN.
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, gender, protected veteran status, disability, or any other basis protected by federal, state or local laws.
Job Type: Full-time
Pay: From $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Retirement plan
- Vision insurance
Schedule:
- Monday to Friday
Work Location: In person
Salary : $90,000
