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Regulatory Compliance Engineer
2 months ago
Position Title: Quality Engineer
Employment Type: Full Time
Location: Springdale, AR
Department: Quality Assurance
Reporting Structure: Reports to DOQ
Role Summary:
The Quality Engineer collaborates closely with the engineering team to comprehend essential quality design specifications and ensures that products adhere to necessary regulatory standards. This role is instrumental in developing, monitoring, and enhancing ISO 13485 and 21 CFR 820 quality system procedures to meet compliance requirements effectively and efficiently while supporting organizational objectives.
Key Responsibilities:
- Identifying opportunities for quality enhancement.
- Ensuring adherence to established quality standards throughout processes.
- Compiling reports through data collection, analysis, and summarization.
- Meeting deadlines for product delivery while maintaining quality.
- Actively engaging in root cause analysis for failures and CAPAs.
- Gathering, organizing, and disseminating information related to supplier quality and process improvement.
- Documenting procedures and work instructions in line with corporate and ISO standards.
- Establishing and executing process control plans, including capability studies and Gage R&R studies.
- Providing quality documentation to the manufacturing team, such as control plans and visual aids.
- Monitoring production processes to ensure compliance with control plans and customer specifications, including fit, function, and reliability.
- Developing and documenting incoming inspection processes and providing in-process QA support.
- Tracking nonconforming materials and leading Material Review Board (MRB) activities.
- Taking a lead QA role in interactions with suppliers and contractors.
- Conducting investigations on product complaints.
- Ensuring timely execution of all quality inspections.
- Authoring and reviewing 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.
