REPORTS TO: Head of Quality
Email Resume To: Amber Murray; Email: amber@exokeryx.com
STATUS: Full Time
POSITION SUMMARY
As part of ExoKeryx’s commitment to developing and launching cutting edge exosome-based tests and platforms, we are growing our Quality team. This QA Manager position is a key role, requiring an individual who acts with minimal direction to drive the development, maintenance, and monitoring of our Quality system, under the guidance of our Head of Quality. This individual is a hard-working team player experienced with implementation and operation of Quality Systems conforming to ISO 9001/13485/15189 and/or GMP/CLIA. She/he works hand-in-hand with R&D and Operations to ensure the day-to-day operation of our Quality System to support test lab services, product development/manufacturing/installation/servicing activities, and other business operations. This individual exhibits excellent communication skills, a goal-oriented mentality, and a strong sense of ownership for project goals and timelines in our fast-paced startup environment.
ESSENTIAL DUTIES
- Serve as Principal for document/change control function
- Serve as Principal for quality records and management function
- Create and maintain quality system procedures/work instructions and associated forms
- Participate in the development and maintenance of product design documentation (user needs, product requirements, hardware/material/software requirements/specifications, DMR content)
- Serve as QA reviewer/approver of plans, protocol, and reports for design V&V activities
- Serve as QA reviewer/approver of plans, protocols and reports for process qualification/validation activities
- Serve as QA reviewer/approver of plans, protocols, and reports for supplier/product qualification activities
- Serve as QA representative for product change review/approval process
- Serve as primary QA contact for supplier-related Quality concerns
- Lead supplier auditing activities
- Lead supplier performance assessment activities
- Serve as QA reviewer of Service Lab test reports
- Administer/manage personnel training activities
- Administer/manage CAPA process
- Administer/manage Quality System internal audit activities
- Administer/manage Management Review activities
- Administer/manage equipment calibration control activities
- Administer/manage preventive maintenance activities
- Participate in product risk management activities
- Participate in product design review process
- Participate in product development phase gate activities
- Participate in supplier selection/approval activities
- Participate in other design activities as necessary
- Participate in the process of dispositioning nonconforming product
- Participate in product complaint handling/investigation
- Participate in the collection, analysis, and presentation of various performance metrics (product and Quality System)
- Other tasks as assigned
EDUCATION/EXPERIENCE/SKILLS
- Bachelor’s or Master’s degree in Biology, Biochemistry, Molecular Biology, Bioengineering, or a closely-related technical field
- Minimum of 8 years of experience with implementation and/or operation/maintenance of Quality Systems conforming to GMP/QSR (21 CFR, Part 820 and Part 11), ISO 13485, and/or ISO 9001
- Minimum of 5 years of experience in lead QA role in the following types of environments:
- Development and/or manufacturing of diagnostic medical products (IVDDs), ideally including software-controlled electro-mechanical instrumentation
- Operation of medical laboratory testing services (CLIA, ISO 15189)
- Significant experience in both mature and startup environments
- Significant experience using PC tools for custom document/form design
- Significant experience in selection/implementation/validation of ERP/LIMS/eQMS/eDMS applications
- Experience being responsible for making critical Quality decisions independently
