Advanced Quality Engineer

📁
Engineering
📅
191AH Requisition #
JOB SUMMARY:
The Advanced Quality Engineer leads product development quality initiatives through identifying, investigating, planning and conducting activities aimed at insuring robust and quality design and manufacturability of medical devices and components during development.  Is responsible to bridge the gap between product engineering, production, supply chain and quality with respect to quality improvements, compliance and cost management.

ESSENTIAL/PRIMARY DUTIES:
  • Plan, lead and manage quality deliverables on product development projects
  • Responsible to ensure that the design, and design changes, complies with all specified regulatory agencies. (FDA, ISO, UL, CSA, etc.)
  • Daily involvement in making decisions and/or providing technical data for decisions that impact compliance with design specifications.
  • Internally communicate with Engineering, Purchasing, Program Management and Product Engineering on opportunities for quality improvement
  • Perform or lead root cause analysis on part or product quality issues during early launch
  • Assist in the development of dimensional control strategies
  • Managing risk analysis through such tools as FMEAs, DOEs, capability analysis, etc.
  • Ensure that customer requirements are incorporated into product functional specifications and lead risk and failure analysis (U,D&PFMEA) to ensure functional specification requirements are fully met during process/design validation
  • Review manufacturing processes, collaborate on process improvement and value enhancement opportunities.
  • Coordinate with Supplier Quality the integration of customer requirements to the supply chain
  • Participate in Item Qualification/Commercialization activities from protocol development, to testing, to a completed final report.
  • Internally escalate potential product/process quality issues and develop a plan with suppliers to resolve
  • Develop, track and report out on quality progress for development projects
  • Provide technical and administrative support as needed.
  • Assist in the design, procurement, and qualification of gages and instruments
  • Integrate Program lessons learned in APQP activities
  • Perform work in accordance with IS14971 and ISO13485 standards

SECONDARY DUTIES:
  • Midmark Production System (MPS) concepts to identify and eliminate non-value added tasks and/or activities in the various areas of responsibility.
  • Actively involved in creating documents related to engineering function.  Documentation includes, but not limited to, layout drawings, detail drawings, assembly drawings, Bill of Materials, Change Orders, product and component test specifications and design records
  • Actively lead or participate as a member of product research teams to acquire detailed product and user knowledge.
  • Design and analyze complex parts and assemblies to applicable specifications.  Parts include, but not limited to, Sheet Metal, Plastic Injection Molded, Plastic Vacuum Formed, Aluminum Die cast, Steel Sand cast, and Weldments.
  • Perform statistical analysis of all design and development data related to quality design and development; collect, interpret, develop SPC limits and organize results

EDUCATION and/or EXPERIENCE:
  • Bachelor Degree in Engineering or associated fields, or equivalent industry experience.
  • 2+ years experience in Quality Assurance, including Quality systems, standards, metrics, and tools.
  • 2+ years of experience in the medical device industry
  • Understanding of medical device quality systems and applications is desired.
  • Ability to effectively influence and negotiate with all levels of an organization and leading effective/successful change initiatives.

COMPETENCY/SKILL REQUIREMENTS:
  • Certified Quality Engineer (CQE) / Certified Quality Auditor (CQA) preferred.
  • Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab.
  • Strong written and verbal communication skills
  • Knowledge of FDA and ISO regulations

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Versailles, Ohio, United States

📁 Engineering

Requisition #: 181G2

Versailles, Ohio, United States

📁 Engineering

Requisition #: 1916X

Versailles, Ohio, United States

📁 Engineering

Requisition #: 19185