Bachelors of Science
EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED: (list required and preferred separately)
- Provides Quality Engineering leadership across all of Operations.
- Directly supports Quality Systems, process improvement initiatives, process auditing and supplier quality activities.
- Provides guidance and direction for product review activities, product audits, and calibration.
- Responsible for establishing and promoting professional working relationships with both internal and external associates and customers, in development of quality plans, procedures, and test methods.
- Provides leadership in QRB, CAPA's, and Quality Cell Shutdowns
- Provides support in PQRB's, environmental monitoring and validation activities
- Responsible for overseeing the Supplier Quality program including Supplier Audits.
- Responsible for interpretation and application of sampling plans and statistical techniques (e.g. SPC, DOE).
- Responsible for overseeing the Calibration program.
- Responsible for developing, reviewing and approving work instructions, material specifications and associated engineering drawings for all of Operations.
- May concurrently manage multiple major and minor projects and/or serve in the capacity of a group team leader.
KNOWLEDGE, SKILLS AND ABILITIES: (list required and preferred separately)
- Associate Engineer (Grade 16) : Minimum of an A.A. /A.S. (B.S. preferred) in a relevant scientific discipline including working knowledge of Lean/Progressive Manufacturing and Quality disciplines.
- Engineer (Grade 17) : Minimum of either a B.S. in a relevant scientific discipline or ASQ CQE, and 3 years of equivalent professional experience including working knowledge of Lean/Progressive Manufacturing and Quality disciplines.
- Senior Engineer (Grade 18) : Minimum of a B.S. in a relevant scientific discipline, and ASQ CQE, and 5 years of equivalent professional experience including working knowledge of Lean/Progressive Manufacturing and Quality disciplines.
This position may require the use of personal protective equipment during various tasks/activities including but not limited to, gloves, masks and safety glasses.
- Good understanding of statistical methods and sampling plans
- Good understanding of standard test methods and instrumentation
- Good understanding of process / quality improvement techniques (Green Belt, Black Belt, six-sigma, Lean manufacturing, etc.)
- Good group facilitation, problem-solving, time-management and project management skills
List activity requirements and percentage of time : KEY: Not at all (0%), Occasional (1-33%), Frequent (34-66%), Constant (67-100%)
Climbing: Not at all (0%) Bending: Occasional (1-33%) Kneeling/Crawling with force: Not at all (0%)
Pulling: Occasional (1-33%) Reaching Above Head: Occasional (1-33%) Twisting at waist: Occasional (1-33%)
Lift above shoulders: Occasional (1-33%) Lift from floor level: Occasional (1-33%)
Medium work: Physically handle objects up to 50 lbs. frequently.
Stand for 6 hours/day Sit for 8 hours/day Perform repetitive tasks/motions Have good manual dexterity
Have good eye/hand/foot coordination Hear alarms/telephone/normal voice Have Clarity of Vision
Near Acuity ( Clarity of vision at 20 inches or less) Far Acuity ( Clarity of vision at 20 feet or more) Distinguish colors
WORKING CONDITIONS: Biomedical manufacturing environment. Potential hazards include exposure to:
Hazardous chemicals: Occasional (1-33%) Blood or body fluids: Occasional (1-33%)
Extreme conditions, hot or cold: Occasional (1-33%) Communicable diseases: Occasional (1-33%)
Saw Blades, needles or other sharp objects: Occasional (1-33%) Unprotected heights: Not at all (0%)
Moving mechanical parts: Occasional (1-33%) Latex exposure: Occasional (1-33%)