Senior Manager - Quality Engineering in Seattle, WA at Apex Life Sciences

Date Posted: 5/16/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Senior Manager of Quality Engineering for a medical device client in Seattle! Please see below and apply if interested!

Job Summary: As the Sr. Manager of Quality Engineering, you will be responsible for overseeing the quality of products throughout the entire product life cycle, including Design, Development, Production and Post-Production activities.  Oversees the Quality Engineering team, which consists of Design Quality, Product Quality, and Supplier Quality.

  In this job you will:

  1. Ensures that all direct reports are familiar with, trained on and follow all Quality System procedures related to their jobs which can affect the quality of products or services provided to our customers and that changes to procedures are reviewed, approved and validated prior to implementation.
  2.  Ensures all regulatory-driven requirements for all products and services in all intended markets are mapped into product specifications and are traceable.
  3.  Demonstrates quality system compliances with US, Canadian, EU and other worldwide regulatory requirements.
  4.  Acts as the Subject Matter Expert (SME) for electro-mechanical testing to meet IEC 60601, EMC and UL requirements
  5. Acts as the SME for the Risk Management program and provides expertise to ensure compliance with ISO 14971, through all phases of the product life cycle.
  6. Works with New Product Development teams to ensure that product design projects are executed per the client specs.
  7. With the assistance of other functional leaders, interfaces with FDA, notified bodies, and other regulatory authorities to demonstrate compliance with worldwide regulations
  8. Manages and develops a team of Quality Engineering professionals across the department.  Provides appropriate mentoring, appraisals, and discipline of direct reports. Ensures that all direct reports are familiar with, trained on, and follow all Quality Management System procedures related to their jobs.
  9. Implements business unit (BU) goals and objectives as related to areas of responsibility, and sets Quality goals and objectives for the Quality Engineering team.
  10.  Ensures that resources and activities are aligned with the BU objectives.
  11. Effectively communicates progress, problems, and plans. Escalates issues requiring attention in a timely manner and with a sense of urgency to manager and BU leadership team as necessary.
  12. Conducts Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implements corrective actions to eliminate quality problems.
  13. . Uses relational databases and reporting tools to collate and analyze quality data.  Provides technical expertise in the use of statistical data analysis tools (e.g. Minitab).
  14.  Creates implements and teaches new quality systems as required.

     Travel Required:   Some travel required

 Supervisory responsibilities (if applicable):

Directly supervises up to twelve employees.  Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities include interviewing, hiring and training employees; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 Qualifications: 

  • Bachelor's degree (B.S.) in Engineering discipline or equivalent degree. Master’s degree preferred.
  • Minimum of 7 years’ experience in engineering related industry, of which 4 years must be in the medical device industry.
  • Minimum of 4 years’ experience in a Manager and/or Supervisory role.
  • Direct experience with FDA QSR and ISO 13485 compliance.
  • Expertise in the development, validation, and manufacture of medical devices.
  • Expertise with electro-mechanical equipment required, including ISO 14971, IEC 60601, EMC and UL requirements
  • Knowledge of the Software Development process, ISO 62304, a plus.

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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 employeeservices@apexsystemsinc.com or 844-463-6178.