Quality Engineer III
4 weeks ago
Position Scope/Summary: The Quality Engineer III is primarily responsible for identifying problems, collecting data, analyzing trends, reporting findings, and initiating corrective and/or preventive actions related to in-process, product, and equipment quality issues. This role encompasses overseeing the quality aspects of qualifying and validating molds, products, processes, and equipment.
Position Requirements:
- Identify problems, collect and analyze data, report findings, and initiate corrective and/or preventive actions.
- Manage Non-Conformance Reports (NCRs) from opening to closure.
- Handle complaints from opening to closure.
- Drive Continuous Quality Improvement across systems, documents, software, and technical tools, updating procedures as necessary.
- Take ownership of product lines and engage in customer-facing roles.
- Report internal and external quality problems and trends.
- Execute validations and coordinate activities between Engineering, Manufacturing, and Quality, including qualification and validation processes.
- Monitor and improve Statistical Process Control (SPC) systems, sampling plans, and statistical methods.
- Conduct Cost of Quality reporting and analysis as needed.
- Provide training to personnel to enhance technical skills, job knowledge, and performance.
- Develop control plans and Process Failure Mode and Effects Analysis (PFMEAs).
- Plan, prepare, and conduct Internal Audits as assigned.
- Lead Material Review Board (MRB) and Corrective and Preventive Action (CAPA) meetings.
- Collaborate with other departments as a member of problem-solving teams.
- Represent the company with customers, vendors, and external auditors.
- Prepare for and participate in audits such as Customer, Supplier, and FDA inspections.
- Contribute to inputs for management review meetings.
Qualifications:
- Bachelors Degree in a technical field or equivalent work experience.
- Required Minimum five (5) years of experience in a similar field.
- Certification as an Internal Auditor. Proficient in problem-solving methodologies, math, statistics, and reading comprehension.
- Strong understanding of Quality Management Systems (QMS). Excellent oral and written communication skills.
- Demonstrated knowledge of Quality System Regulations (e.g., Complaint, NCR, root cause analysis).
- Proficient in quality statistics (e.g., AQL, sampling).
- Preferred At least two (2) years of experience in a supervisory or management role.
- Demonstrated leadership in teams and projects. Strong organizational skills. Previous experience in a plastic injection molding environment.
- Green Belt in Six Sigma preferred.
- Specialized Knowledge: Experience in medical devices or other FDA-regulated industries.
- Comprehensive understanding of ISO 9001, ISO 13485, JPAL MHLW Ordinance 169, and/or FDA QSR regulatory requirements.
- Proficiency in MS Word, Excel, and Access.
- Desired experience in Measurement System Analysis (MSA), SPC, Mini-tab, Infinity, sterilization, and clean room environments.
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