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- Identify quality issues, conduct data analysis, and initiate corrective and preventive actions.
- Manage Non-Conformance Reports (NCRs) and customer complaints, ensuring thorough investigation and resolution.
- Drive continuous quality improvement efforts, including updating procedures and implementing new systems and tools.
- Serve as a primary contact for customer-facing quality matters and ensure timely reporting of internal and external quality trends.
- Execute validations and coordinate activities between Engineering, Manufacturing, and Quality departments.
- Monitor and enhance Statistical Process Control (SPC) systems, sampling plans, and statistical methods.
- Conduct cost-of-quality reporting and analysis as necessary.
- Provide training to personnel to enhance technical skills and job knowledge.
- Develop control plans, Process Failure Mode and Effects Analysis (PFMEAs), and execute Internal Audits.
- Lead Material Review Board (MRB) and Corrective and Preventive Action (CAPA) meetings.
- Collaborate with cross-functional problem-solving teams and assist Inspectors in Quality Assurance activities.
- Assume Quality Manager duties as required and represent the company in interactions with customers, vendors, and auditors.
- Prepare for and participate in audits, including those conducted by customers, suppliers, and regulatory agencies.
- Contribute to inputs for management review meetings.
- Bachelors Degree in a technical field or equivalent working experience.
- Minimum five (5) years' experience in a similar field, with certification as an Internal Auditor.
- Proficient in problem-solving methodologies, math, statistics, and Quality Management Systems (QMS).
- Excellent communication skills and familiarity with Quality System Regulations.
- Preferred: Two (2) years' experience in a supervisory or management role, Green Belt in Six Sigma, and prior experience in plastic injection molding.
- Specialized knowledge of working in FDA-regulated industries and understanding of ISO standards and regulatory requirements.
- Computer literate with proficiency in MS Word, Excel, and Access, with desirable experience in MSA, SPC, and clean room environments.
- Medical, dental, and vision benefits
- Company-paid life insurance and disability benefits
- Generous Paid time off and 10 paid Holidays
- 401k Plan with Company Match
- Tuition Reimbursement
Quality Engineer III - Upland, United States - Medix
Description
Overview: As a Quality Engineer III, you will play a pivotal role in ensuring the quality and reliability of our products through problem identification, data analysis, and continuous improvement initiatives. Your responsibilities will encompass addressing in-process, product, and equipment-related quality issues, while also managing the qualification and validation processes for molds, products, processes, and equipment. This position requires a keen eye for detail, strong problem-solving skills, and the ability to collaborate effectively across departments to uphold regulatory standards and drive quality excellence.
Responsibilities:
Education & Qualifications:
Benefits: