Quality Manager, Research & Development

Scismic.comis supporting the growth of a biotech company that is working to automate experiments and provide the life science community more time to focus on their R&D.
We are currently seeking a Quality Manager (QA) to join our growing R&D team!

General role:
The candidate will oversee regulatory compliance of all research and development activities.

Responsibilities:
- Act as designated Management’s Representative per 21 CFR 820.20(b) (3)
- Responsible for the establishment and maintenance of a quality system that meets the business needs of the company and medical device regulatory requirements of the US FDA, as well as any other state or international requirements as applicable to IVD products that the company may develop and distribute.
- Facilitate the conduct and documentation of periodic Management Reviews
- Coordinate with clinical laboratory QA to ensure that the following quality system functions are adequately performed to FDA medical device regulations:
- Document Control
- Complaint Handling
- Internal Audits
- CAPA system
- Training system
- Supplier Selection/ Approval/ Purchasing Controls.
- Provide Quality Support for Design Control projects
- Interact with external regulatory consultants on the coordination between quality and regulatory for new design projects including what types of analytical and clinical studies and associated data are needed for FDA regulatory submissions.
- Facilitate the set up and generation of design control and risk management documents for the - - Design History File (DHF) and risk management file.
- Demonstrate a commitment to diversity, inclusion, and cultural awareness through actions, interactions, and communications with others

Basic qualifications:
- BS/MS with at least 5 years industry experience or PhD with at least 3 years industry experience.
- Minimum applicable work experience: 5 years at an IVD or medical device company or CLIA lab with FDA cleared/approved LDT (Lab Development Test) assays
- Strong interpersonal skills to interact with all company personnel, contractors and consultants.
- Excellent oral and written communication skills.
- Strong working knowledge of US regulations including but not limited to 21 CFR 820
- Experience in setting up and maintaining a medical device quality system.

Job Type: Full-time

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Research Experience: 1 year (Preferred)

Work Location:

• One location