Quality Engineer III

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:

1. Identify quality issues, conduct data analysis, and initiate corrective and preventive actions.
2. Manage Non-Conformance Reports (NCRs) and customer complaints, ensuring thorough investigation and resolution.
3. Drive continuous quality improvement efforts, including updating procedures and implementing new systems and tools.
4. Serve as a primary contact for customer-facing quality matters and ensure timely reporting of internal and external quality trends.
5. Execute validations and coordinate activities between Engineering, Manufacturing, and Quality departments.
6. Monitor and enhance Statistical Process Control (SPC) systems, sampling plans, and statistical methods.
7. Conduct cost-of-quality reporting and analysis as necessary.
8. Provide training to personnel to enhance technical skills and job knowledge.
9. Develop control plans, Process Failure Mode and Effects Analysis (PFMEAs), and execute Internal Audits.
10. Lead Material Review Board (MRB) and Corrective and Preventive Action (CAPA) meetings.
11. Collaborate with cross-functional problem-solving teams and assist Inspectors in Quality Assurance activities.
12. Assume Quality Manager duties as required and represent the company in interactions with customers, vendors, and auditors.
13. Prepare for and participate in audits, including those conducted by customers, suppliers, and regulatory agencies.
14. Contribute to inputs for management review meetings.

Education & Qualifications:

• Bachelor’s 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.

Benefits:

• 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