Quality Assurance Manager


What you'll be doing 

As our Quality Assurance Manager, you will be responsible for the quality and inspection of all our client's products. This includes testing and inspection of manufactured products in accordance with customer specifications. 

Main Duties include: 

  • Hands-on management and directing the daily quality control activities
  • Supplier engagements and monitoring
  • Collaborate with Engineering and Operations for schedule and delivery
  • Provide tactical oversight for the HDM Quality Management System.
  • Ensure accurate and current documentation
  • Act as liaison with customers and suppliers
  • Address daily QMS demands to include CAPA
  • Testing and inspection of products at various stages of the production process and compiles and evaluating statistical data to determine and maintain the quality and reliability of injection molded and/or manufactured products in accordance with customer specifications
  • Interprets engineering drawings, schematic diagrams, and formulas; confers with appropriate staff to determine quality and reliability standards
  • Tests products at specified stages in the production process for various quality criteria, including dimensions, performance, and mechanical/electrical/chemical characteristics
  • Writes quality program documentation, including quality plans, incoming inspection instructions, CTQ dimensional/visual quality requirements (DVQR), and new product inspection techniques
  • Assists Purchasing Department with maintaining appropriate vendor quality
  • Communicates with internal and external customers verbally and in writing regarding quality standards and specifications
  • Identifies quality-related customer issues and develops corrective action plans
  • Coordinates or performs dimensional analyses, initial inspections, Material Review Board (MRB) activities, SPC-SQC data analyses, etc.
  • Functions as a resource for ISO 9001:2000, ISO 13485, and QSR program requirements.

What we hope to see you have

  • Must possess good communication and organizational skills
  • Computer experience with Windows, Excel, and Word required.
  • Experience with ISO 9001, ISO 13485, GMP and GLP desired.
  • Experience in a Quality Assurance managerial position in the Medical Device industry

Who We Are

Every product and company is unique, and once we understand your company and your unique product needs and goals we can get to work. We have designed products in nearly every category and industry, including medical devices, consumer products, transportation innovations, and defense and industrial solutions. Our team will carefully and skillfully listen to you to design your product based on its form and function and your input. Even if we didn’t design and prototype your product, our innovative approach to contract manufacturing makes us the right company to produce it.

At Harbor Designs & Manufacturing we take the time to understand your mission, bottom line, technical details, and regulatory requirements. We put together a comprehensive manufacturing plan by competitively bidding, auditing and qualifying global suppliers and defining production processing criteria. Then we develop assembly instructions with incoming and outgoing inspection requirements to ensure your product is manufactured to the highest level of quality. Delivered on time, and on budget. We produce your product in a uniquely tailored turnkey solution, so you can focus on what matters- running your business.

Why Join Us

  • Unlimited PTO
  • Paid Sick Leave
  • Health, Dental, and Vision
  • Short Term Disability, Long Term Disability and Life Insurance 
  • 401K 

More information and to apply, visit our website here

Job Type : Full-Time
Education Level : ""
Experience Level : Mid to Senior Level
Job Function : ""
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