Senior Quality Engineer in Seattle, WA at Apex Life Sciences

Date Posted: 9/16/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Quality Engineer for a biotech client located in Seattle! Please see below and apply if interested!

Responsiblities

  • Serve as Quality representative on product development and sustaining engineering projects as a core team member to ensure work products comply with procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
  • Lead and facilitate Risk Management activities during product development as well as product lifecycle, and maintain Risk Management file (RMF, RMP, HA, FMEAs, RMR).
  • Review and approve project deliverables with cross-functional teams (e.g. plans, requirements, specifications, product risk management, test methods, hardware/software validation, traceability, design reviews, reports, process validation, etc.).
  • Collaborate on resolution of product related issues and root cause analysis for non-conforming material (NCR), root cause investigation for corrective and preventive actions (CAPA). 
  • Collaborate in efforts to resolve complex technical and Quality-related problems for Sustaining Engineering.
  • Lead quality process improvement initiatives.
  • Train and coach cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations.
  • Participate in support of external regulatory agency audits and inspections.
  • Work under consultative direction toward long-range goals and objectives. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results with guidance from superior as needed.
  • Perform other related duties as assigned.

Qualifications:

  • BS in Life Science or Engineering discipline
  • 5+ years of experience in regulated industry including pharmaceutical and/or medical device, preferably with IVD (in vitro diagnostic devices).
  • Knowledge and experience to ensure quality in new product development and product lifecycle.
  • Strong working knowledge of Quality System from design control to release of finished product, including FDA 12 CFR 820, ISO 13485, ISO 14971.
  • Strong working knowledge quality processes and principles, with a focus on development and verification/validation activities.
  • Ability to perform risk assessment and maintain risk management files (RMP, HA, FMEAs, RMR).
  • Ability to author and implement standard operating procedures.
  • Ability to develop and drive to completion quality process improvement initiatives.
  • Working knowledge of software development for medical devices a plus.
  • Ability to multi-task, prioritize, meet/exceed deadlines and hold themselves, and others accountable.
  • Self-Starter with the ability to work effectively within a team in a fast-paced, ever-changing environment.
  • Ability to mentor and provide guidance to junior members of the QE staff.
  • Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
  • ASQ certification or CQE a plus.

If you are interested in this opportunity please send your resume to LHaas@ApexLifeSciences.com

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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