- Review and approved Device History Records
- Work on technical investigations relating to product complaints
- Oversight of vendor/supplier management program - change notifications, audit schedule, status tracking, etc.
- Ensure site inspection readiness for both internal and external audits
- Bachelors degree with approx. 8-10 years of Quality experience in medical device, combination product experience preferred
- Direct experience with medical device complaints investigations and inspection readiness
- Experience working directly with FDA/notified bodies
- Must be authorized to work in the united states without sponsorship
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Sr. Manager, Quality - Billerica, United States - EPM Scientific
Description
Job Description
Job DescriptionTitle: Manager/Sr. Manager, Quality (Medial Device)
Location: Billerica, MA
A leading pharma/med device company is seeking a Manager/Sr. Manager to spearhead Quality activities related to their combination products. The Sr. Manager of Quality will be responsible for all aspects of QA for medical devices manufactured on site or through third party contractors.
Responsibilities:
Qualifications:
If you are curious to hear more, please don't hesitate to apply
Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency
Company Description
A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\rJob Responsibilities:\r
•\tConducting Post Market Activities and Post Market Surveillance\r
•\tManaging Customer and Product Complaint Investigation programs\r
Education and Experience:\r
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r
•\tBachelor's degree\r
•\tComputer proficiency