Job Details

GENERAL DESCRIPTION:

The Quality Engineer is responsible for supporting the organization with all quality and compliance related support for the life cycle and development of medical devices, including new product development and maintenance of released products. The QE is recognized as a technical leader and resource. Assists in operational, managerial, and engineering activities to ensure that the quality of the product and the services are achieved, maintained, and improved.

ESSENTIAL FUNCTIONS:

1. Leads Q.A. Engineering efforts and is a key technical contributor during New Product Development.

2. Assists with audit (internal/supplier) coordination.

3. Provides expert consultation in one or more areas of quality control, quality systems, design assurance, and design & development activities to find new and novel opportunities to improve quality and reduce costs. Collects and analyzes quality metrics

4. Actively participates with new product project development and risk assessments, assists with design inputs for manufacturability, test and inspection procedures, acceptance criteria and complaint analysis. Assist with process validation; process capabilities; and process improvements.

5. A key contributor in design for manufacture, test and successful design transfer to ensure that new products shall meet specifications/requirements. Provide Statistical Process Control (SPC) support.

6. Reviews and analyzes protocols, validations, reports, design and verification tests to determine that Company standards are met. Conducts failure and reliability testing, and root cause analysis as a result of complaints, non-conforming material and product, etc.

7. Performs Failure Modes, Effect and Criticality Analysis (Design or Process FMEAs/ FMECAs) with project team members.

8. Recommend alterations in product to improve quality of products and/or procedures; Review and approve proposed manufacturing and specification changes.

9. Supports/reviews design history file deliverables for assigned projects, completion and adherence to design control procedures; Exercise considerable judgment to define manufacturing requirements and processes using LEAN MANUFACTURING concepts.

10. Reviews current processes and procedures against actual practices and update/improve processes and procedures.

11. Analyze product, customer, and regulatory requirements to determine tools, fixtures and equipment requirements for assigned projects.

12. Complies with U.S. Food and Drug Administration (FDA) regulations, ISO13485, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

13. Participate in Kaizen Events (Lean) and follow-up implementation.

14. Resolves and/or facilitates the resolution of problems including identifying causes to prevent reoccurrence.

15. Attend and participate in a variety of meetings and groups to integrate activities, and communicate issues, obtain approvals, resolve problems and maintain a specific level of knowledge pertaining to new developments, requirements, and policies.

16. Supports manufacturing suppliers to provide quality and processing improvements. Assists in resolution of quality and process related issues. Assist QA Manager with other duties as required.

17. Performs related functions and responsibilities, on occasion, as assigned.

MINIMUM QUALIFICATIONS:

· Bachelor’s degree required in an Engineering or Engineering Technology discipline.

· Minimum 5 years of relevant experience in a Quality or Design Assurance position in a Medical Device or other highly regulated industry.

· ASQ CQE Certification (or in process of obtaining) preferred.

· (SPC) Statistical Process Control charts and control charting concepts useful for Six Sigma Quality Improvement preferred.

· Experience with quality trending analysis and reporting

· Design of Experiments (DOE) to identify/improve critical variables in -process preferred.

· Experience plastic extrusion and RF welding preferred.

· Working knowledge of Microsoft Word, Excel, PowerPoint and Outlook; Experience using CAD Systems and drafting tools, machine tools, hand and power tools, and electronic test devices.

· Expert understanding of quality control practices, standards and principles

· Expert understanding of statistical process controls, root cause analysis and supplier controls.

· Expert understanding of Quality Management Systems and Risk Assessment/Hazard Analysis.

· Expert understanding of FDA and ISO guidelines for medical devices required.

· Strong communication skills and accountability to project deliverable timing.

WORKING CONDITIONS:

Varying from a good working conditions in office environment with regular exposure to manufacturing areas to somewhat undesirable working conditions with exposure to fumes, noise, grease and dirt, with no element continuously present to the extent of being disagreeable