Senior Engineer, Development Quality (LS-220632)
Start Date: ASAP
Location: Southeast
Duration: 3-6 Months
Pay Rate: DOE
Type: Contract
Job Description
This contractor will be working with a small group of 5-6 employees to support the design control.  This is a start up environment. The contractor may also be asked to mentor/train Jr. employees on the Quality Engineering aspects at hand. A design assurance engineer assures new or modified products conform to requirements and establish compliance with the quality system.  He/She  is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates  organizational success by protecting patient/user safety and meeting business needs.

In this position the contractor will be responsible for the following: 
  • Lead on-time completion of Design Control Deliverables 
  • Create and ensure on-time execution of  Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional  root-cause analysis investigation & resolution activities
  • Lead Risk Management activities from product Concept through Commercialization 
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support and ensure internal & external audit responses
  • Support and ensure on-time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable  customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications 
  • Accountable for development, execution and analysis of  biocompatibility and sterilization qualifications
  • Complete Document Change Request Reviews in a timely and objective manner Develop and lead other team members.
  • Perform other duties and responsibilities as assigned by management. 

Requirements: 
  • 10-15+ years experience
  • Heavy Design Controls
  • Remediation
  • Risk Management
  • FMEA
  • Quality Engineering
  • Implantable Device is a MUST
  • Experience working in a broader enterprise/cross-division business unit model 
  • Working understanding of FDA, GMP, and ISO 13485·         
  • Working understanding of the following standards 60601, 62304, &/or 14971
Education:
  • Engineering/Technical Degree

Other: 
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 10%, including internationally.
  • Ability to maintain regular and predictable attendance.





















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