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Quality Engineer, Combination Products & Medical Devices

Irvine, CA 92602

Posted: 11/15/2022 Employment Type: Direct Hire/Perm Job Category: Quality and Compliance,Engineering Job Number: 488014 Country: United States Is job remote?: Yes

Job Description

Primary responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.

Responsibilities:

  Perform QA activities related to Combination Product and Medical Device Development:

Ensure compliance with company policies and procedures. 

Perform design control and risk management activities according to Quality System

Partner within Quality and R&D to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met

  Perform 3rd party supplier management activities such as review 3rd party design control activities

  Support the creation of regulatory submission documentation

  Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.

Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.

Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents

  Apply knowledge of global regulations, guidance's, and Corporate and Function standards.

Lead/assist in the preparation of and support regulatory agency and internal audits.

 
Qualifications:

Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area.

4+ years of industry experience in Quality Assurance, Development or healthcare related field. Less experience considered with advanced degree. Medical device experience required. Combination Product and 3rd party supplier management experience desired.

  Strong understanding of regulations and standards affecting combination products and medical devices.

  Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills

Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management.

  Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues

Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities

Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required.

  Capable of clearly presenting and justifying quality requirements to management

Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).


 
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