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September 19 2018

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Senior Quality Engineer

Apex Life SciencesSeattle, WA8/17/2018
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Job Description


Apex Life Sciences is seeking 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, tracecapability, 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 tasks as assigned.
Appropriate qualifications:
   » BS in Life Science or Engineering discipline
   » 5+ years of practice in regulated industry including pharmaceutical and/or medical device, preferably with IVD (in vitro diagnostic devices).
   » expertise and practice to ensure quality in new product development and product lifecycle.
   » Strong working expertise of Quality System from design control to release of finished product, including FDA 12 CFR 820, ISO 13485, ISO 14971.
   » Strong working expertise quality processes and principles, with a focus on development and verification/validation activities.
   » capability to execute risk assessment and maintain risk management files (RMP, HA, FMEAs, RMR).
   » capability to author and implement standard operating procedures.
   » capability to develop and drive to completion quality process improvement initiatives.
   » Working expertise of software development for medical devices a plus.
   » capability to multi-task, prioritize, meet/exceed deadlines and hold themselves, and others accountable.
   » Self-Starter with the capability to work effectively within a team in a fast-paced, ever-changing environment.
   » capability to mentor and provide guidance to junior members of the QE staff.
   » Strong verbal and written English communication expertise with an capability 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 [Click Here to Email Your Resumé]

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EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, discapability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified candidates 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, Contact Us by our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.

EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, discapability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified candidates 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, Contact Us by our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.

Job Snapshot

Employment Type Contractor
Job Type Engineering, QA - Quality Control
Education 4 Year Degree
practice Not Specified
Manages Others Not Specified
Industry Other Great Industries
Required Travel Not Specified
Job ID 877796

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Company Overview

Apex Life Sciences
On Assignment's U.S. life sciences businesses, Lab Support and Valesta Clinical Research Solutions, have been re-branded as Apex Life Sciences. The U.S. divisions of Lab Support and Valesta are leaders in the scientific, engineering, and clinical research staffing and services industry. The new name was chosen to leverage the national brand of On Assignment's Apex Systems, a leader in the technology staffing and services industry. For over 30 years, Lab Support and Valesta have provided top talent for contract, contract-to-hire, and direct hire positions in the life sciences industries. With hundreds of thousands of prosperous matches over three decades, the divisions have built reputations as the best in the business.
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Seattle, WA
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Post Date: 08/17/2018 / Viewed 61 times
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