Quality Manager (Medical Device)

Our client is a fast-growing medical device startup focused on developing and commercializing innovative Class II medical devices. Their team is passionate about quality, compliance, and making a real impact in healthcare. Currently, they are looking to add a Quality Manager (Medical Device) to their team.

Salary/Hourly Rate:

$110k – $130k DOE

Position Overview:

We are seeking a dedicated and experienced Quality Manager (Medical Device) to serve as the primary point of contact for all quality and regulatory matters. This individual will oversee the ongoing management of the Quality Management System (QMS), with a strong focus on post-market surveillance and compliance. Additionally, the Quality Manager (Medical Device) will lead the Customer Relationship Management (CRM) system to enhance customer engagement and streamline business operations. This role also plays a vital part in supporting supply chain and logistics activities, collaborating with manufacturers and suppliers, addressing product-related inquiries, and ensuring smooth documentation processes. The Quality Manager (Medical Device) will be instrumental in upholding the highest standards of product safety, quality, and regulatory compliance.

Responsibilities of the Quality Manager (Medical Device):

• Lead post-market surveillance activities and ensure continuous compliance with 21 CFR 820 requirements for Class II medical devices.
• Act as the primary liaison for all quality and regulatory affairs, representing the company in both internal and external communications.
• Utilize Dot Compliance QMS software to manage quality processes and documentation.
• Collaborate with R&D and support design control and product lifecycle activities.
• Monitor and manage vendor quality, including audits, agreements, and compliance tracking.
• Handle non-conforming product processes, CAPA, change control, and complaints.
• Lead CRM system implementation and manage customer interactions and feedback.
• Support supply chain and logistics, including coordination with manufacturers and suppliers, documentation, and product inquiries.
• Respond to customer complaints and inquiries by gathering and analyzing relevant data.
• Assist the company and team as needed – must have a “no task is too small” mindset and a strong desire to be a supportive team player.

Required Experience/Skills for the Quality Manager (Medical Device):

• Minimum of 7 – 10 years of quality experience in medical devices, including post-market surveillance and compliance.
• Strong communication, organizational, and interpersonal skills.
• Familiarity with CRM systems and vendor management.
• A strong, principled approach to quality, someone who is passionate and firm in upholding standards.
• Takes a firm, standards-driven approach to quality, resilient in maintaining compliance and best practices.
• Deeply passionate about quality, driven to uphold high standards that align with the company’s mission.

Preferred Experience/Skills for the Quality Manager (Medical Device):

• Experience with Dot Compliance QMS software (preferred).
• Background in pharma/biotech with a strong interest in medical devices.
• Experience in supply chain/logistics and customer service.
• A fast learner with a flexible mindset and team-first attitude.
• Ability to work onsite as needed (hybrid flexibility).
• Champions quality while fostering constructive dialogue and cross-functional cooperation.

Education Requirements:

• Bachelor’s degree in science, Business, Engineering, or a related field.

Benefits:

• Medical, vision, and dental (Aetna Tri-State Plan) – fully covered for individuals. Partial coverage for families.
• 401(k). 
• Opportunity to work in a mission-driven startup with real impact.

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EOE/M/F/D/V/SO