Sr. Quality Tech/Engineer

7 days ago

Maple Grove, MN, United States Custom Search Full time

Our smaller cardiovascular start-up client is adding a pivotal role: Manufacturing Quality Senior Technician/Engineer, in which your expertise will directly contribute to advancing life-saving medical devices. This position offers the unique chance to work on the process development of tissue processing and the implementation of stringent quality inspections, ensuring the highest standards in the manufacture of sterile medical devices.

Why This Role Stands Out:

- Impactful Work: Be at the heart of developing structural heart implants, making a tangible difference in patients' lives.
- Professional Growth: Collaborate with cross-functional teams, including R&D, Operations, and Regulatory Affairs, enhancing your professional network and skill set.
- Innovation-Driven Environment: Engage in continuous improvement initiatives, driving quality systems and product development processes forward.
- Regulatory Excellence: Gain in-depth experience with regulatory submissions, ensuring compliance with FDA QSR, ISO 13485, EU MDR, and other standards.

Key Responsibilities:

- Execute lab-based process development runs to refine tissue processing of bovine pericardium.
- Implement and oversee quality controls to ensure tissue performance, biocompatibility, and repeatability.
- Establish and maintain tissue-specific manufacturing procedures, inspection criteria, and in-process controls.
- Develop and nurture relationships with testing vendors, coordinating sample drop-offs and pickups.
- Review technical documentation to support regulatory submissions.
- Communicate effectively with R&D, Operations, and Regulatory Affairs teams.

Additional Responsibilities:

- Drive continuous improvement in quality systems and product development processes.
- Collaborate on process development reports.
- Perform other duties as assigned.

Desired Profile:

- 3-5 years of experience in quality assurance, with a strong preference for experience in structural heart technologies.
- Proven experience in quality inspections for tissue processing.- Excellent communication skills for effective interaction with cross-functional teams and vendors.
- Familiarity with FDA QSR, ISO 13485, EU MDR, ISO 14971, ISO 5840, and ISO 22442.
- Sound judgment in reviewing technical data, protocols, and reports.

Requirements:

- Capable of managing multiple priorities and working under pressure.
- Willingness to work in cleanroom environments with bovine pericardium.

Authority and Responsibility:

- Accountable for the quality and compliance of assigned deliverables.
- Authority to execute tasks supporting process development activities under the direction of the Principal Design Assurance Engineer.

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