Job Summary: We are seeking an experienced Quality Assurance Manager to lead our quality assurance function for bioprocess single-use systems and medical molded parts. The ideal candidate will have extensive experience in quality assurance, leadership qualities, and a deep understanding of GMP, ISO 13485, and other regulatory requirements. This role involves managing and guiding a large team to ensure the highest standards of product quality and compliance.
Key Responsibilities:
- Oversee the quality assurance function for products manufactured in the USA and India.
- Lead and manage a large team of quality assurance professionals.
- Ensure compliance with GMP, ISO 13485, and other relevant regulatory requirements.
- Develop and implement quality assurance policies and procedures.
- Conduct regular audits and inspections to ensure product quality and compliance.
- Collaborate with cross-functional teams to address quality issues and implement corrective actions.
- Provide leadership and guidance to the quality assurance team, fostering a culture of continuous improvement.
- Monitor and report on key quality metrics and performance indicators.
- Stay updated with industry trends and regulatory changes to ensure compliance.
Qualifications:
- Bachelor's degree in a relevant field; advanced degree preferred.
- 15-25 years of experience in quality assurance, preferably in bioprocess single-use systems and medical molded parts.
- Strong knowledge of GMP, ISO 13485, and other regulatory requirements.
- Proven leadership and team management skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a fast-paced and dynamic environment.
- Strong analytical and problem-solving abilities.
Preferred Skills:
- Experience with bioprocess single-use systems and medical molded parts.
- Familiarity with quality management systems and tools.
- Ability to manage multiple projects and priorities simultaneously.