Quality Assurance Engineer III - Manufacturing FDA Regulatory QA experience needed! in Cranberry Township, PA at Johnson Service Group

Date Posted: 9/24/2021

Job Snapshot

Job Description

JobID: 386506

Johnson Service Group is seeking a Quality Assurance Engineer III, Design Assurance for a 6 Month Contract Assignment.

While on this assignment you are able to apply for a full-time position. 

Reporting to the Sr. Manager or Manager of Quality Design Assurance, the Quality Design Assurance Engineer will be responsible for leading Design Assurance activities in collaboration with cross-functional personnel.

Responsibilities:

  • Participate in core team meetings and design reviews to serve as primary representative of Quality and Regulatory on the product development 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 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
  • Team oriented with strong communication skills

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 (ISO or FDA)

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

Work Conditions:

  • Office Environment
  • May travel up to 10%
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