(Sr) Quality Manager

Custom Search Inc.; Minneapolis (MN); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Custom Search Inc. seeks a Manager of Quality to lead hands-on QMS across a cardiovascular medical device program, guiding regulatory readiness and ISO certification as development advances toward commercialization.

You will partner with R&D, Manufacturing, Regulatory, and Clinical teams to strengthen the quality system in a lean startup environment. The role focuses on executing design controls, risk management, and CAPA, while coordinating with FDA and external auditors.

Formación

• Bachelor's degree in life sciences, engineering, or related field.
• Significant medical device quality experience in QMS operations and cross-functional projects.
• Experience with Class II and III devices and regulatory submissions is ideal.

Responsabilidades

• Manage day-to-day operation and continuous improvement of the QMS, incl. electronic QMS, controlled documents, procedures, and workflows.
• Lead quality system certification prep, internal audits, management reviews, CAPA, and inspection readiness; coordinate responses and follow-up actions.
• Partner with R&D and Manufacturing on design controls, risk management, verification/validation, manufacturing controls, and validation master planning.
• Support supplier qualification, supplier quality activities, and product quality with manufacturing quality personnel.
• Collaborate with FDA, auditors, consultants, and external partners; identify compliance risks and practical solutions.
• Coordinate cross-functional projects, priorities, and resources, guiding quality for commercialization readiness.

Conocimientos

Quality management

Cross-functional collaboration

Regulatory experience

Educación

Bachelor's degree in life sciences or engineering

Herramientas

Quality Management System (QMS)

ISO 13485

Descripción del empleo

Our start-up cardiovascular company seeks a Manager of Quality to provide hands‑on leadership across quality systems as we advance our cardiovascular medical device program through clinical development and toward commercialization. This role will partner closely with R&D, Manufacturing, Regulatory, and Clinical teams to maintain and strengthen an established quality system, support ISO certification, and advance IDE and PMA activities.

The successful candidate will combine strong quality systems expertise with practical regulatory experience and enjoy working directly on deliverables in a lean organization. Near‑term priorities include supporting planned 2026 PMA modules covering R&D, manufacturing, and preclinical information, as well as regulatory and quality readiness for anticipated study enrollment in early 2027.

Your role with the company:

Manage the day-to-day operation and continuous improvement of the Quality Management System, including electronic quality system administration, controlled documents, procedures, and workflows.

Lead quality system certification preparation, internal audits, management reviews, CAPA, and inspection readiness; coordinate responses and follow-up actions.

Partner with R&D and Manufacturing on design controls, risk management, verification and validation, manufacturing controls, and validation master planning.

Support supplier qualification, supplier quality activities, and product quality, working collaboratively with manufacturing quality personnel.

Work with FDA, auditors, consultants, and other external partners as needed; identify compliance risks and recommend practical solutions.

Coordinate cross‑functional projects, priorities, and resources, providing quality guidance as the company prepares for commercialization.

Desired profile:

Bachelor's degree in life sciences, engineering, or a related field.

Significant medical device quality experience, including responsibility for quality system operations and cross‑functional project execution.

Experience with Class II and Class III devices; cardiovascular medical device experience preferred.

Strong knowledge of applicable FDA requirements, ISO 13485, design controls, risk management, and medical device manufacturing quality.

Experience maintaining an established quality system and preparing for ISO certification and regulatory or quality system audits.

International experience supporting clinical research, regulatory submissions, or quality compliance, ideally in Europe, Canada, Australia, and New Zealand.

Ability to manage electronic quality systems, controlled documentation, CAPA, supplier quality, and multiple concurrent projects.

Start‑up experience preferred; ability to apply sound quality practices in a resource‑conscious environment.

Leadership Profile

A collaborative, detail-oriented leader who builds trust across functions, communicates clearly, and follows through on commitments. This person must be comfortable owning operational work, influencing without a large team, and balancing quality requirements with development and business priorities. The ideal candidate is both a “doer” and a leader.