Director of Quality - Hybrid
Calling all dynamic leaders and motivational professionals in the life science sector! An exciting opportunity awaits you at one of the top 10 medical device companies in the United States, situated in the New Jersey area. We are actively seeking individuals to spearhead Quality initiatives within our organization. You will take control in this unique position to promote innovation and quality in the creation of medical devices. As part of your duties, you'll be mentoring and developing a group of gifted people and encouraging a collaborative and innovative culture across the company.
Responsibilities:
- Oversees the creation, administration, and upkeep of the company's document control system in addition to employee training and the creation and revision of quality procedures.
- Carries out the processes and procedures required to support product portfolios, such as vendor audits, testing, etc.
- Understanding ISO 13485/ISO 9001.
- Oversee corrective action groups and create customized corrective action plans and procedures.
- Ensuring that GMP and ISO compliance are understood, implemented, and followed.
- Responsible for CAPA's and change control activities.
- Responsible for all QA and QC requirements staying maintained.
- Keeps the executive team informed about project and departmental developments, offering guidance to senior management on strategies concerning product quality and safety.
Requirements:
- Degree in life sciences (B.S., M.S., and/or Ph.D.).
- Minimum of 10-15 years of experience working and leading in Quality Control or Quality Assurance/Compliance at a Medical Device company.
- Extensive knowledge on regulatory requirements regarding manufacturing and ISO 9001/ISO 13485.
- Strong demonstration of leadership.
- Specific skills include, but are not limited to,
- Oversee hiring provide coaching, and guidance and build a highly innovative QC team.
Salary/Benefits
- Salary Range: $200,000-$240,000
- Benefits: Medical, Dental Insurance, 401K, etc.
