Quality Assurance Engineer III

Omnicell Milpitas , CA 95035

Posted 2 months ago

Quality Assurance Engineer III

Omnicell is excited to be adding to our Quality Team a Quality Assurance Engineer III. Reporting to the Senior Manager Production Quality and located at the Omnicell facility located in Milpitas, CA, the Quality Assurance Engineer III will be responsible for Production Quality activities. Their primary responsibilities will be to prepare and maintain necessary documentation, monitor production quality performance to identify opportunities for improvements, act as a liaison between manufacturing and quality inspectors, and promote quality awareness.

Responsibilities:

  • Assist in the establishment of quality acceptance criteria and activities including but not limited to incoming, in-process and final inspection

  • Participate as Material Review Board member and assist in disposition of non-conforming materials.

  • Work with manufacturing to document, markup, and communicate changes to parts and assemblies within change control process

  • Collaborate with design quality and engineering personnel to determine critical part features and review manufacturability of design

  • Participate in change control activities

  • Prepare, supervise and report suitable and effectual changes

  • Support new product introductions to ensure QMS requirements are followed

  • Ensure compliance to internal QMS documentation and ISO 13485 and ISO 9001

  • Provide input into Process Validation activities

Additional Responsibilities:

  • Oversee/Coordinate internal rework activities

  • Support development of design and process FMEAs

  • Support the Quality Department objectives and goals by managing or participating in Quality projects

  • Manage and/or participate in CAPAs as required

  • Act as a liaison between Quality and other Omnicell functional departments

  • Participate in Quality Management Review meetings

Required Knowledge and

Skills:
  • Ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, vendors, and employees of all level

  • Ability to work collaboratively with peers and team members

  • Change agent who accepts and supports new ideas and processes

  • Strongly demonstrated written and verbal communication and presentation skills to all levels of an organization

  • Refined multi-tasking and time management skills

  • Ability to consistently balance sense of urgency with diplomacy/empathy

  • Ability to make decisions and execute directives

  • Strongly demonstrated attention to detail

  • Commitment to cost reduction/controls

  • Strongly demonstrated organizational and project management skills

  • Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)

  • Ability to work under tight deadlines and handle multiple detail-oriented projects

  • Team builder, self-starter, organized, analytical and decisive

Basic Qualifications:

  • Bachelor's degree

  • Minimum five (5) years' experience in a quality production environment

  • Experience working with complex electro-mechanical systems

  • Experience with broad variety of measurement and quality data analytic techniques

Preferred Qualifications:

  • ISO 13485 or FDA regulated medical device experience

  • Electro-Mechanical experience

  • SAP experience

  • Agile PLM experience

Work Conditions:

  • Office Environment

  • May travel up to 10%

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Quality Assurance Engineer III

Omnicell