Staff Quality Assurance Engineer

2 weeks ago

San Diego, California, United States BD Full time
Job Summary

The Staff Quality Engineer is a key member of the New Product Development Team, responsible for QA-related R&D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects.

Key Responsibilities
  • Manage all quality aspects of the design control process, including quality planning, verification and validation planning and execution, risk management, and regulatory and compliance support.
  • Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
  • Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
  • Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.
  • Active participant in the development of product requirements, product system hazard analysis, and design reviews.
  • Lead/own or support CAPA investigations and CAPA closures.
  • Ensure product technical files and Design History Files are complete and auditable.
  • Follow Quality System Regulations and established procedures.
  • Responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, product launches, and process improvements.
  • Proactively engage partners to drive consensus and resolve issues in a timely fashion.
  • Provide statistical support and expertise and analytical problem-solving for product.
  • Acts as a resource for colleagues with less experience.
Requirements
  • Requires a minimum of a BS degree in science, engineering, or relevant subject area.
  • Minimum 8 years' experience with emphasis on R&D development, Quality Engineering, and Design Control.
Knowledge, Skills, Abilities
  • Proficient in Microsoft Office suite (Excel, Word, PowerPoint).
  • Excellent verbal and written communication skills.
  • Attentiveness to details with strong organizational skills.
  • Ability to work independently as well as part of a team.
  • Ability to use root cause analysis tools and execute corrective action plans.
  • Knowledge of quality systems and regulatory standards requirements, including 21 CFR 820, ISO 13485, and ISO 14971.
  • Knowledge in lean tools and techniques, including Practical Problem Solving, A3, PFMEA, and/or Fishbone diagrams.
  • Familiarity with GMP and regulatory requirements for medical devices.
  • Experience with hardware development within a regulated environment is preferred.
  • Thorough understanding of risk management and quality by design is preferred.
  • Experience in production and process control is preferred.
  • Quality Engineering Certification (ASQ) or equivalent is preferred.
  • Experience in Project/Program Management is preferred.

BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility, or veteran status.

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