Quality Engineer: Digital Technology Solutions

Senior Quality Engineer

1. PURPOSE:

Provide engineering support in the development and maintenance of company’s quality systems.

2. EDUCATION / EXPERIENCE REQUIRED:

BSME, BSEE, BS Chemistry, BS Microbiology, or BS Biology

5 – 9 years experience with BS

3 – 7 years experience with MS

0 – 4 years experience with Ph.D.

3. KEY JOB RESPONSIBILITIES:

Under general supervision reviews product designs, test protocols and co-develops critical characteristics/tolerances for initial testing and subsequent routine manufacturing controls.

Participates in design evaluations/valuations.

Participates in process evaluations (e.g. FMEA's), develops and executes manufacturing process valuations and determines appropriate sampling plans for subsequent routine production.

Devises and implements methods and procedures for inspecting, testing and evaluating production. Provides technical QA support to assigned inspection and manufacturing area(s).

May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to quality control or may otherwise specialize in one or more specific product group(s) or manufacturing processes.

Requires a wide application of principles, theories and concepts in the field plus a working knowledge of other related disciplines.

Participates in the training of new and lower level quality engineers.

Provides imaginative, thorough and practical solutions to a wide range of difficult problems.

Erroneous decisions or recommendations or failure to achieve results might cause serious delays and considerable expenditure of resources.

COMPLIANCE:

Examples of required areas of compliance include but are not limited to:

· Quality Systems (including Product Complaints, Corrective and Preventive Actions (CAPA), Internal Audits, Good Manufacturing Procedures (GMP), and Good Documentation Practices (GDP))

· Sarbanes-Oxley (SOX)

· Health Care Compliance (HCC)

· Government Contract Compliance (GCC)

· Environmental Regulations

· Records Management

· Johnson & Johnson Business Conduct and Employee Policies