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Omnicell
Cranberry Township, PA, United States
30+ days ago
Omnicell
Cranberry Township, Pennsylvania, United States
30+ days ago

Description

Are you a seeking your next career opportunity as a Quality Engineer?  Omnicell is looking for our next Quality Design Assurance Engineer III to support sustaining products.  In this role, reporting to the Sr. Manager of Quality Design Assurance, you will be responsible for leading Design Assurance activities of released product in collaboration with sustaining engineering and other cross-functional personnel.  This Quality Engineer role will support changes to current products working through their life cycles.

Responsibilities:

  • Participate in core team meetings and design reviews to serve as primary representative of Quality and Regulatory on the product sustaining teams
  • Review and approve all design verification and validation protocols, plans and records
  • Ensure that design outputs meet the design inputs
  • Drive risk management file activities and updates
  • Lead the Defect Review Board for assigned products and verify acceptable resolution of design defects
  • Assist in the establishment of quality acceptance criteria and activities including but not limited to incoming, in-process and final inspection for new products
  • Ensure production equivalency is reviewed, documented and tracked as required per verification and validation protocols
  • Participate in change control activities to ensure the Device Master Record (DMR) is maintained
  • Ensure compliance to internal QMS documentation and ISO 9001 or ISO 13485
  • Establish quality metrics for design control conformance to demonstrate the level of effectiveness of the process. 

Additional Responsibilities:

  • 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
  • Self-starter, organized, analytical and decisive

Basic Qualifications:

  • Bachelor of Science degree
  • Minimum (3) years quality/regulatory experience or relevant design/manufacturing engineering experience
  • Experience in product and process development
  • Experience working in a Regulated environment

Preferred Qualifications:

  • Minimum (5) years quality/regulatory experience
  • ISO 13485 or FDA regulated medical device experience
  • IEC62304 Software Lifecycle Experience
  • Experience working with complex electro-mechanical systems
  • Experience working in an ISO regulated environment

Work Conditions:

  • Office Environment
  • May travel up to 10%


Job Information

  • Job ID: 57287222
  • Location:
    Cranberry Township, Pennsylvania, United States
  • Position Title: Quality Design Assurance Engineer III
  • Company Name: Omnicell
  • Job Function: Engineering
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 2-3 Years
  • Required Travel: 0-10%

Please refer to the company's website or job descriptions to learn more about them.

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