Senior Quality Engineer
Company: ClearPoint Neuro, Inc.
Location: Solana Beach
Posted on: August 7, 2022
Job Description:
ClearPoint Neuro's mission is to improve and restore quality of
life to patients and their families by enabling therapies for the
most complex neurological disorders with pinpoint accuracy.
Applications of the Company's current product portfolio include
deep-brain stimulation, laser ablation, biopsy, neuro-aspiration,
and delivery of drugs, biologics, and gene therapy to the
brain.
We are seeking a Sr. Quality Engineer for our San Diego, CA office
who will be responsible for product design assurance, continuous
improvement of processes and oversight of global device
registration.
-Responsibilities for this Role
- Support new product development projects and sustaining design
and process changes
- Support continuous improvement projects
- Implementation of changes to QMS processes
- Registration and organization of devices in new
geographies
- Compiling data for and presenting at periodic quality reviews
and management reviews
- Review of quality records
- QMS alignment with new or updated regulations
- Support quality tasks including CAPA, NCMR and complaint
assessment
- Support external and regulatory audits, and execute internal
audits for regulated products to assess the effectiveness of the
QMS
- Other special quality related projects / responsibilities as
needed -Skills and Qualifications
- 3+ years of experience in medical devices or related highly
regulated field
- Advanced experience in statistical analysis
- Experience supporting external audits
- Familiarity with global regulatory requirements
- Excellent written and verbal communication skills
- Good follow through and closure of responsibilities /
tasks
- Logical decision making and thought processing
- Strong team player, using both internal and external resources
to execute activities
- Communicates opinions, facts and thoughts with clarity,
transparency and honesty
- Sets clear and high expectations and holds self and others
accountable for decisions and results achieved.
- Seeks multiple perspectives and listens openly to others'
points of views
- Enables and demonstrates the courage to speak up on issues and
risks
- Demonstrates ownership of results within (and beyond) area of
responsibility
- Looks for opportunities for continuous improvement
- Demonstrated understanding of quality management system
elements and interactions
- Strong public speaking skills / presentation experience
- Self-driven with strategic, tactical, and analytical
mindset
Education - - - - - - - -Bachelor's Degree in Mechanical
Engineering, Biomedical Engineering, or equivalent
Keywords: ClearPoint Neuro, Inc., San Diego , Senior Quality Engineer, Engineering , Solana Beach, California
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