What are the responsibilities and job description for the Medical Device Quality Director position at Orchestra BioMed?
Job Overview
The Director of Quality will lead the development and management of Orchestra BioMed's quality systems to ensure compliance with regulatory requirements. This role will oversee all quality-related activities for the development, testing, and manufacturing of medical devices and combination products.
Responsibilities
Requirements
About Us
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies.
The Director of Quality will lead the development and management of Orchestra BioMed's quality systems to ensure compliance with regulatory requirements. This role will oversee all quality-related activities for the development, testing, and manufacturing of medical devices and combination products.
Responsibilities
- Develop quality strategies aligned with business objectives to ensure compliance, product integrity, and patient safety.
- Oversight of document control, training programs, CAPA systems, non-conformance handling, and internal/external audits.
- Provide direction and oversight to manage events (e.g., deviations, vendor nonconformances) that may impact compliance status or create business risk.
Requirements
- Proven experience in device/pharma/combination products with at least 10 years of quality responsibility and at least 5 years in a leadership role managing a quality team.
- B.A./B.S. undergraduate degree in life sciences or engineering. Master's/Ph.D. or other relevant advanced degree preferred.
About Us
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies.
