Quality Engineer

Essential Job Functions:

• Customer complaint oversight/management
• Calibration program oversight/management
• Risk management plan and life cycle maintenance oversight/management required for adherence to ISO 14971 (I.e. pFMEA/control plans)
• Statistical Techniques oversight/management
  • Data analysis and trending to drive continuous improvement
• Lead/support Non-Conformance
• Leads/supports Corrective and Preventative Action (CAPA's)
• Annual Project/Process Improvement Goals (I.e. SPC implementation/eDHR/Etc...)
• Development of Operational Quality Systems (process/procedures/test methods/etc...)
• Value stream change management (DCRs)/engineering change requests (ECR's/validation review and approvals (DOE's/IQ/OQ/PQ), test method development and validations (GRRs)
• Critique, evaluate, approve and prepare technical documentation including justifications and/or rationales based on sound scientific or engineering principles (ISO/ASTM/USP).
• Assist in troubleshooting and finding remedies on escalated operational quality system challenges while providing timely, risk based and actionable information to site leadership when further escalation is required.
• Training on various quality system elements to ensure compliance and enable continuous

Improvement

• Manages many aspects of multi-phased development projects, from inception through planning, prototyping and evaluation while participating in product quality planning activities to ensure the successful introduction of new products equipment and processes (I.e. PPAP, etc...)
• Support Internal/Customer/Corporate/Registrar/Supplier/FDA Audits.

Other Job Functions:

• Performs other job-related and department-related duties as assigned.

Supervisory Responsibility:

• Plan, organize, analyze, and implement assigned quality improvements and initiatives in support of site objectives.
• Communicate and implement appropriate actions in response to non-conformances, complaints, CAPAs, audit findings, supplier issues, etc...

Experience, Knowledge, Skills and Abilities required:

• Education: Bachelor's degree in a related field (Engineering, Quality, Business Management)
• 3+ years of demonstrated experience in a manufacturing environment.
• Combinations of education, training, and experience to successfully accomplish responsibilities.
• Knowledge of compliance and processes.
• Strong self-motivation, the ability to work independently and within a team environment. Ability to work with others in a positive and collaborative manner.
• Must have excellent attendance record.
• Ability to work safely and with minimal supervision
• Ability to clearly communicate and interact with all levels of personnel professionally
• Ability to follow written and verbal directions and complete work independently
• Ability to adhere to workplace rules
• Excellent attention to detail.
• ASQ certification preferred (CSSGB, CQE)
• Experience with IQMS is a plus.
• Practical knowledge of FDA QSR 820, ISO13485 and/or ISO 9000 and plastics injection molding technology preferred. Experience with SPC, GRR, Process control, Design of experiments, Failure mode and effects analysis, and other problem-solving tools preferred.
• Preferred but not required: candidate with hands-on engineering knowledge of plastic injection molding including part manufacturability, processing and tooling design.

Work Environment/Physical Requirements:

• Ability to stand for long periods of time.
• Able to push, pull, lift, and carry up to 30 pounds.
• Standing, walking, bending, reaching, kneeling.
• Possibility of exposure to noise, uncontrolled temperatures, and chemicals.