What are the responsibilities and job description for the Quality Engineer (Medical Devices) position at Accentuate Staffing?
Accentuate Staffing is working with a growing medical device company north of Raleigh, NC. The role involves participating as a member of a Cross Function Customer Focus team and supporting the QA Manager in maintaining the Quality Management System. The incumbent will ensure adherence to Quality System Procedures by providing assistance to QA personnel.
Key Responsibilities:
• Collaborate in creating and assessing Purchasing Specifications and receiving inspection criteria for new product introductions.
• Develop a thorough understanding of the manufacturing process before transferring it to production, including training QA and manufacturing personnel.
• Establish and uphold verification and inspection protocols, techniques, and sampling plans to guarantee the fulfillment of customer requirements and product specifications.
• Lead the development and upkeep of Limit Samples and other inspection tools.
• Oversee all Risk Assessment activities.
• Guide QA Specialists in managing the Nonconforming Materials Control Process, ensuring timely investigation, control, documentation, resolution, and closure of non-conformances.
• Investigate and document findings tied to Corrective Action and Preventive Actions (CAPA), conducting follow-up verifications post CAPA Plan implementation.
• Assess, summarize, and present quality data and Key Performance Indicators (KPIs) to ensure effective problem resolution and identify potential trends or system issues.
• Provide assistance to other Managers and Engineers concerning Cost Savings and continuous improvement initiatives.
• Serve as the point of contact for quality concerns when interacting with customers and suppliers.
• Develop, maintain, and evaluate training modules and effectiveness assessments related to quality procedures and practices.
• Review and authorize Validation Protocols and Reports.
• Assist in executing Validation activities as necessary.
• Engage with Suppliers to address incoming quality matters.
• Conduct Supplier Audits.
• Perform Internal Audits.
• Carry out additional assigned duties.
Minimum Requirements:
• Bachelor's degree (4-year) or equivalent applicable experience.
• Proficiency in using Quality Management Tools.
• Competence in MicroSoft Office Suite.
• Strong written communication skills.
• Effective verbal communication abilities.
• Proficient in interpreting regulatory requirements and standards.
• Strong analytical skills, including Cause and Effect Analysis.
Preferred Qualifications:
• Certification as an ISO 9001 or ISO 13485 Auditor.
• Experience conducting Supplier Audits/Evaluations.
- • Familiarity with selecting appropriate Statistical Tools.
