What You'll Be Doing 

As our Quality Assurance Manager, you will be responsible for the quality management system and inspection of all our client's products in accordance with client specifications. Products will range from medical devices to consumer products and industrial devices. 

Main Duties and Responsibilities: 

• Oversee in-house assembly QA, specifically medical devices 
• Inspections of in process technical assembly and clean room assembly 
• Hands-on management and directing the daily quality control activities
• Supplier engagements and monitoring
• Collaborate with Engineering, Operations, and Sourcing for schedule and delivery
• Oversee vendor factory inspection teams 
• Management of customer-supplied or Harbor generated product specific QMS records (specifically Medical Devices)
• Provide tactical oversight for the HDM Quality Management System
• Ensure accurate and current documentation
• Ensure appropriate training
• 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.
• Oversees ISO 9001:2000, ISO 13485, and QSR program requirements

Who You Are 

• Experience in quality assurance management in the Medical Device Industry
• Must possess good communication and organizational skills
• Computer experience with Windows, Excel, and Word required
• Experience with 2100 CFR or ISO 9001, ISO 13485, GMP and GLP required

Who We Are

Harbor Designs & Manufacturing helps both multinational brands and diverse startups and inventors bring new and often disruptive products to life! We have partnerships and collaborations with universities, hospital systems, and federal labs bringing new technologies to production. Every product and company is unique, and once we understand our client's unique product needs and goals we get to work, guiding them through the rough seas of product development, regulatory compliance, manufacturing, and supply chain strategy. We are their safe Harbor for design and manufacturing, working as part of their team so they can stay focused on what matters – running their business. When it’s a fit for the project we also offer in-house technical assembly, clean room assembly, warranty repair, and logistics support. We have designed and manufactured products in nearly every category and industry with a special emphasis on medical and biomedical devices but we also make products for the consumer market, rail and transportation markets, energy innovation, ag-tech/ aqua-tech, robotics, IOT devices, wearables, defense, and cyber security markets.

While Harbor Designs & Manufacturing opened its doors in 2008, we are very much in a high growth start-up mode and are looking for key team members who can help refine systems, build and lead teams, or just be strong team members open to direction. Upward advancement and lateral moves within the organization are always prioritized over new hires when an interest or proficiency is shared with management. Harbor offers unlimited PTO and supports continuing education for those interested in honing or expanding their skills. We pride ourselves on having a collaborative team environment where suggestions aren’t just heard but implemented. If you want to be a part of a dynamic growing team and work on cutting-edge technologies and innovations, apply today!

Why Join Us

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