What are the responsibilities and job description for the Quality Assurance Manager Medical Devices position at Orchestra BioMed?
Job Description
The Director of Quality will be responsible for overseeing the quality assurance processes for medical devices and combination products developed by Orchestra BioMed. This role will require collaboration with cross-functional teams to ensure compliance with regulatory requirements and drive continuous improvement initiatives.
Key Responsibilities
Qualifications
About Our Company
Orchestra BioMed accelerates high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies.
The Director of Quality will be responsible for overseeing the quality assurance processes for medical devices and combination products developed by Orchestra BioMed. This role will require collaboration with cross-functional teams to ensure compliance with regulatory requirements and drive continuous improvement initiatives.
Key Responsibilities
- Ensure compliance with global regulatory standards for quality, including GxP and Q8, Q9, and Q10 requirements.
- Develop and manage a high-performance quality team focused on accountability and exceeding expectations.
- Collaborate with Regulatory Affairs, Product Development, Pharmaceutical Development, Clinical, and Marketing teams to drive evaluation of products and ensure compliance with regulations.
Qualifications
- Minimum 10 years of quality experience in device/pharma/combination products, with at least 5 years in a leadership role managing a quality team.
- Bachelor's degree in Life Sciences or Engineering, Master's/Ph.D. or other relevant advanced degree preferred.
About Our Company
Orchestra BioMed accelerates high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies.
