QA Manager Director
QA Manager Director
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The QA Manager / Director will be responsible for managing all activities of the Quality Assurance department and maintaining the Companys Quality Management System in accordance with applicable international standards and regulatory requirements.
Managing the QA team and sharing supervisory responsibility of one employee in Logistics and carrying out supervisory responsibilities in accordance with AVS policies and applicable laws.
Furthermore:
- Establish and maintain the AVS Quality Management System (QMS) ensuring ongoing compliance with applicable domestic and international quality assurance for AVS medical device design manufacture and distribution.
- Manage the Companys QMS including QA Inspection Document Control Medical Device PostMarket Vigilance and Complaint Handling and Evaluation Risk Management processes (ISO 13485 and 14971 Standards) Corrective/Preventive Action Environmental Monitoring and Equipment Calibration processes
- Support applicable improvements to the QMS and appropriate integration of processes into Santen corporate systems.
- Support Santen Global Teams for improvement of Global Medical Device policies standard operating procedures and systems to the extent possible.
- Establish and maintain product inspection acceptance or rejection and release activities including ensuring there are adequate numbers of qualified employees in these Departments.
- Assist in the development of domestic or international regulatory filings and act as liaison with Santen Ltd. and Santen Inc. Quality Regulatory and R&D groups where requested.
- Actively participate in the AVS management team and provide leadership in Quality for the Production and R&D departments.
- Interact create and maintain quality laboratory or service agreements (as appropriate) with vendors suppliers subcontractors and consultants as defined by established procedures and applicable regulations or standards with a customer serving face.
- Other duties may be assigned.
Qualifications :
What you will bring to the role
- Bachelors degree (B.A. /Sc. from fouryear college or university
- At least 7 years related experience in QA in a medical device manufacturing environment
- Knowledge of the ISO 13485 Quality Management Standard & FDA medical device regulations.
- Must be detailed oriented and able to multitask
- Excellent verbal and written communication skills
- Must be dependable and flexible
- Must be a team player and have experience providing support for numerous internal customers
- PHYSICAL DEMANDS:
- Varied sitting standing and walking
- Ability to lift and carry 50lbs. or less
Additional Information :
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our longterm vision outlined in Santen 2030 we are committed to be a Social Innovator addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin/ancestry religion sexual orientation gender gender identity/ expression age disability medical condition marital status veteran status or any other characteristic protected by law.
If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.
What we offer:
The salary range for the QA Manager position is $110 $130000 depending on experience.
The salary range for the QA Director position is $120000 $170000 depending on experience.
Would you like to learn more about this position. Apply now.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
