Product Quality Specialist
2 weeks ago
Position Title: Quality Engineer
Employment Type: Full Time
Location: Springdale, AR
Department: Quality Assurance
Reporting Structure: Reports to DOQ
Position Summary:
The Quality Engineer collaborates closely with the engineering team to identify and understand essential quality design specifications. This role involves conducting thorough reviews to ensure that products meet all necessary regulatory standards. The Quality Engineer is responsible for developing, monitoring, and enhancing ISO 13485 and 21 CFR 820 quality system procedures to ensure compliance is achieved effectively and efficiently, supporting the overall objectives of the organization.
Key Responsibilities:
- Identify factors for quality enhancement.
- Ensure adherence to established quality standards throughout processes.
- Compile reports by gathering, analyzing, and summarizing relevant data.
- Meet deadlines for product delivery while maintaining quality.
- Engage in root cause analysis for failures and Corrective and Preventive Actions (CAPAs).
- Organize and distribute information related to supplier quality and process improvement.
- Document procedures and work instructions in accordance with corporate and ISO standards.
- Establish and implement process control plans, including capability studies and Gage Repeatability and Reproducibility (Gage R&R) studies.
- Provide quality documentation to the manufacturing team, including control plans and visual aids.
- Monitor production processes to ensure compliance with control plans and customer specifications.
- Develop and document incoming inspection processes and provide in-process quality assurance support.
- Track nonconforming materials and lead Material Review Board (MRB) activities.
- Serve as the primary quality assurance contact in interactions with suppliers and contractors.
- Lead investigations into product complaints.
- Ensure timely execution of all quality inspections.
- Author, issue, and review regulated documents to ensure compliance with Good Manufacturing Practices and 21 CFR 820.
Qualifications:
- Bachelor's degree in Engineering (or equivalent) with a minimum of 3 years of experience in the regulated medical device sector as a Quality Assurance Engineer.
- Strong knowledge of Quality Systems is essential. Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, and Good Documentation Practices is preferred.
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