What You'll Be Doing 

As our Quality Manager you will be responsible for our company's compliance to our QMS (Quality Management System) ensuring all procedure, design controls, manufacturing and batch controls, employee training, calibration records and other necessary documentation are properly captured, stored, and up to date. You will manage both our ISO 9001 QMS for non medical devices, and our ISO 13485 system and FDA registration for medical devices. As an professional with medical QMS management experience you will be the point person for liaising with new and existing clients who know exactly what controls their design and production need, or who rely on your guidance and recommendations. Depending on your experience and interest the roll may extend to providing and billing for hourly guidance, and potentially into managing QA inspectors, but the primary role and immediate need is direct management of the QMS system for compliance internally, and with the vendors the sourcing team manages. You are expected to know and own all aspects of the QMS and be the point person for any customer, registrar, or FDA audits and report to the Director of Quality and Regulatory Affairs for regular guidance and support as needed.

Main Duties and Responsibilities

• Manages the QMS system and ensures accurate and current documentation
• Using hands-on management, directs the daily quality control activities
• Monitors and engages suppliers for compliance to QMS 
• Ensures appropriate training of all team members to QMS and specific job functions 
• Interprets engineering drawings, schematic diagrams, and formulas; confers with appropriate staff to determine quality and reliability standards required
• Supports with testing of 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
• Work with customers, vendors, and internal stakeholders to define appropriate AQLs
• 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 And Preventative Action Plans (CAPA)
• Coordinates and performs dimensional analysis, initial inspections, Material Review Board (MRB) activities, SPC-SQC data analysis, etc.
• Oversees ISO 9001, ISO 13485, and QSR program requirements
• Coordinate annual 3rd party internal audits 
• Hosts and facilitates customer, registrar or FDA audits 
• Oversees in-house Quality Assurance Team (ideally)
• Offers fee for service consulting to clients as needed (ideally)

Who You Are

• Experienced in Quality Assurance, ideally within the Medical device field or another highly regulated industry
• Excellent communication and organizational skills
• Continuous improvement, solution oriented mindset
• Computer literate, with a good understanding of the Microsoft Office Suite, and some data analysis skills
• Experience with 2100 CFR or ISO 9001, ISO 13485, GMP and GLP 

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