Quality Engineer-Medical Device-Contract-Concord, Ca

Provide support and leadership to the Quality Team and all related processes to ensure conformance to customer specifications and compliance with relevant regulatory requirements.

Essential Functions:

  • Responsible for developing and improving the corporate Quality System in conformance to FDA and ISO standards appropriate for world-class suppliers to the medical device industry with the following areas of responsibility:
  • Inspection:
  • Provide support when needed in-process and final inspection processes.
  • Participate in the resolution of all product rejections and returns, internal and external, call and follow-up on Material Review Board Meetings.
  • Provide technical support for inspection department.
  • Audits
  • Internal Audits – Schedule and manage internal quality audits.
  • Third Party Audits – Participate in external quality audits and surveys from customers and regulatory agencies.
  • Complaints/SCARs
  • Ensure timely response to all customer-inquiries including complaints, customer generated Supplier Corrective Action Requests (SCAR’s), and Pulse Systems issued SCARs. 
  • Track and manage the timely resolution of all customer inquires, open SCAR’s.
  • Corrective and Preventive Actions
  • Ensure Corrective And Preventive Action (CAPA) activities are initiated when required.
  • Monitor CAPA activities from initiation, through closure, and verification of effectiveness.
  • Training
  • Train employees, including management, in quality processes and regulatory requirements. 
  • Monitor internal training activities to ensure all employees are trained in accordance with Pulse Systems procedures. 
  • Vendor Evaluation and Approval
  • Manage Vendor Evaluation/Approval/Review process. Conduct Supplier Audits as required
  • Issue and manage Supplier Corrective Action Requests as required.
  • Document Change Orders
  • Work with other departments to define, qualify, and implement Document Change Orders.
  • Manage the Document Control process to maintain revision control on all internal controlled documents.
  • Ensure that Document Change Orders are tracked and implemented in a timely manner.
  • Support the execution of production schedules consistent with company goals and objectives.  Coordinate support from other staff and production personnel as necessary.
  • Be a company champion for quality and compliance.
  • Prepare materials for and participate in Quality review meetings with management.
  • Adhere to general safety rules, manufacturing procedures, company policies and procedures and other ISO guidelines.
  • Work from limited direction as set by the Head of Quality (currently Director of Engineering and Quality).

  Qualifications:

1.     Education and Training

  • A technical or business undergraduate degree; industry experience may be substituted to provide qualification as Quality Engineer.

2.     Required Experience

  • A minimum of 5-7 years of related experience, preferably including: Quality Engineering in a medical device manufacturing environment,  knowledge of medical device manufacturing and related regulatory requirements.

3.     Essential Skills and Abilities

  • Ability to lead by example and manage people and processes in a demanding contract manufacturing environment.
    • Flexibility, adaptability, judgment, and ability to work under pressure to meet schedules and deadlines within quality and regulatory standards.
    • Excellent interpersonal skills; ability to adapt to changing corporate priorities; and ability to maintain good working relationships while dealing appropriately with a variety of contacts within and outside the organization.
    • Ability to work with customers at all levels of the client’s organization.
    • Ability to read blueprints, engineering drawings and sketches, make informed management and technical decisions is required.
    • Ability to work independently, using good judgment, initiative and problem-solving abilities, to follow detailed verbal and written instructions, anticipate likely needs and take appropriate actions, while working with minimal direction.

Pay Range;40-50/hr. DOE

Please send resume to kjohnson@nelsonconnects.com

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