Outstanding Opportunity!
Quality Engineer
1st shift
What you will do:
- Ensure Compliance: Oversee project management and the transition to manufacturing to ensure adherence to GMP, ISO, FDA standards, and customer specifications. Ensure that inspection methods and customer requirements are integrated throughout engineering and production phases.
- Develop Validation Procedures: Create and implement procedures for Process Validations (IQ, OQ, PQ) for both new and customer-supplied molds, ensuring thorough and accurate validation processes.
- Documentation and Coordination: Develop and manage inspection and calibration plans for products and equipment. Control and release new documentation through the engineering change process to ensure compliance with regulatory standards.
- Quality Audits: Conduct and participate in routine audits and evaluations of manufacturing, engineering, tooling, and warehousing activities. Identify areas for improvement and ensure regulatory compliance.
- Enhance Quality Knowledge: Assist the Quality Manager in improving the quality and manufacturing team's understanding of quality initiatives, the Quality Management System, and updates to policies and procedures.
- Review Specifications: Analyze new and revised customer specifications and product drawings. Identify necessary modifications to tooling, techniques, and procedures to meet evolving requirements.
- Technical Documentation: Actively contribute to the development and writing of technical documentation. Stay updated on the latest inspection and testing techniques, integrating new methods as applicable.
- Customer Communication: Effectively communicate with customers to ensure a clear understanding of their requirements. Provide written, verbal, and personal communication to address any concerns or clarifications.
- Collaboration and Reporting: Maintain good working relationships with colleagues and report any issues to your supervisor. Attend work regularly and perform essential duties as required.
What you will need:
- Education and Experience: Associate’s Degree in Quality, Engineering, or a related field, or five years of experience in Quality within a manufacturing environment.
- Technical Skills: Proficiency in SPC, blueprint reading, dimensioning and tolerance. Practical experience with quality tools such as control charts, capability studies, DOE, regression analysis, histograms, and fishbone diagrams.
- Standards Knowledge: Familiarity with ISO 13485:2016, GMP, or similar quality systems. Experience with Minitab and risk management techniques/tools.
- Documentation Skills: Proven experience in writing technical protocols and reports. Ability to analyze data and prepare control plans and inspection instructions.
- Analytical Abilities: Strong knowledge of statistics and experience in data analysis to support validation efforts. Background in Corrective Action & Root Cause Analysis and Continual Improvement.
- Communication: Excellent verbal and written communication skills. Ability to interact diplomatically with team members and customers.
- Computer Proficiency: Strong computer skills, including MS Office.
- Confidentiality: Ability to handle sensitive and confidential information with discretion.
Why Join Us?
- Impactful Work: Contribute to high-quality manufacturing processes and ensure compliance with top industry standards.
- Professional Growth: Develop your skills and knowledge in a supportive environment with opportunities for career advancement.
- Collaborative Culture: Be part of a team that values teamwork, integrity, and excellence.
If you are a dedicated quality assurance professional with a passion for ensuring compliance and driving improvements, we encourage you to apply and become a key player in our team!
If you meet the above qualifications and would like to apply for this position, you may email your up-to-date, professional CV/resume to Tim Dameron @ timothy.dameron2@adeccona.com.
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