Quality Engineer
1 day ago
We are seeking an experienced and meticulous Quality Engineer to enhance our operational quality systems. This role demands a proactive approach to managing
customer complaints, calibration programs, risk management, statistical techniques, and continual
improvement initiatives. The Quality Engineer will play a pivotal role in ensuring compliance with
ISO 14971 and other relevant standards, while supporting various audits and training programs.
Key Responsibilities:
- Oversight and management of customer complaints.
- Supervision of the calibration program.
- Management of the risk management plan and life cycle maintenance, ensuring adherence to
- ISO 14971 (e.g., pFMEA/control plans).
- Oversight of statistical techniques, including data analysis and trending for continuous improvement.
- Leading and supporting Corrective and Preventative Actions (CAPAs).
- Development of operational quality systems (processes, procedures, test methods).
- Management of value stream change management (DCRs), engineering change requests (ECRs), validation reviews, and approvals (DOEs/IQ/OQ/PQ), including test method development and validations (GRRs).
- Critiquing, evaluating, approving, and preparing technical documentation, justifications, and rationales based on sound scientific or engineering principles (ISO/ASTM/USP).
- Assisting in troubleshooting and finding remedies for escalated operational quality system challenges, 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 facilitate continuous improvement.
- Supporting internal, customer, corporate, registrar, supplier, and FDA audits.
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.
- 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
- 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.
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