Senior Quality Engineer
Company: Alphatec Spine
Location: Carlsbad
Posted on: August 7, 2022
Job Description:
Description
Develop and improve, with an emphasis on implementation, inspection
methods, gages, process control techniques, standard operating
procedures, inspection plans, test protocols and test reports to
ensure safety, reliability and efficacy of new and current products
and processes.
Essential Duties And Responsibilities
- Lead management of Quality Engineering Deliverables for New
Product Development
- Lead Supplier Part Qualification for New Product
Development
- Technical interface with contract manufacturing
- Lead Material Review Board (MRB)
- Develop inspection methods, gages and associated drawings and
procedures.
- Support Design Control to ensure efficient effective and
compliant new product launches
- Support suppliers in performing IQ, OQ and PQ processes
- Support Engineering Change Order Review.
- Perform Design For Manufacturing (DFM)
- Provide statistical support to analyze manufacturing processes
and to recommend appropriate process controls for ensuring product
conformance to specification.
- Lead Risk Management efforts in accordance with ISO 14971
- Perform Failure Mode and Effects Analysis (FMEA) for design and
processes.
- Support validations regarding sterilization, cleaning and
shipping.
- Participate in FDA, ISO and other regulatory audits.
- Other duties as assigned.
Requirements
The requirements listed below are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions.
- Knowledge of both US and International medical device quality
system requirements (e.g. 21 CFR Part 820, ISO 13485), and other
applicable standards.
- Extensive knowledge of Solid Works CAD software
- Extensive knowledge of mechanical inspection methods and
equipment
- Extensive knowledge of SPC, DOE, probability and
statistics
- Ability to read, analyze, and interpret blueprints and
GD&T
- Ability to write reports and procedures
- Ability to effectively interact with all levels of the
organization
- Working knowledge of lean principals and implementation
- Ability to develop and maintain strong working relationships
with internal and external customers and suppliers
- Ability to solve complex problems to root cause and prevent
re-occurrence (CAPA)
- Technical writing of procedures and reports
- Detail Oriented
- Good decision making skills and judgment
- The ability to execute plans/strategies to completion
- Extensive knowledge of cleanability/sterilization (steam, EtO
and Gamma) including dose mapping and dose audits.
- Extensive knowledge of biocompatibility requirements
- Must be able to travel up to 25% of the time
Education And Experience
- Minimum Bachelor's degree (BS) from a four-Year College or
university in Mechanical, Biomedical, Industrial, Systems, or
Manufacturing Engineering.
- Six Sigma Black Belt, ASQ CQE (Certified Quality Engineer), ASQ
CQA (Certified Quality Auditor) preferred
For roles based in the United States that require access to
hospital facilities, must be eligible for and maintain credentials
at all required hospitals, including meeting any applicable
physical requirements or vaccination requirements (including the
COVID-19 vaccine, as applicable).
ATEC is committed to providing equal employment opportunities to
its employees and applicants without regard to race, color,
religion, national origin, age, sex, sexual orientation, gender
identity, gender expression, or any other protected status in
accordance with all applicable federal, state or local laws.
Further, ATEC will make reasonable accommodations that are
necessary to comply with disability discrimination laws.
Keywords: Alphatec Spine, San Diego , Senior Quality Engineer, Engineering , Carlsbad, California
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