Quality Engineer - Validation
We are looking for a Validation Engineer to join our client's team in Asheboro, NC. This contract role focuses on validation activities and quality assurance for new product introductions, particularly in the medical manufacturing space. The ideal candidate will bring strong statistical analysis capabilities, hands-on experience with validation protocols, and excellent communication skills to support both internal teams and customer interactions.
Key Responsibilities
- Lead validation efforts across product lifecycle stages, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Develop and execute validation protocols and reports aligned with internal standards and customer expectations.
- Apply Advanced Product Quality Planning (APQP) methodologies to support product development and launch.
- Analyze process and product data using statistical tools to assess performance and ensure compliance.
- Collaborate with cross-functional teams to optimize manufacturing processes and ensure cost-effective, high-quality outcomes.
- Support quality control activities, including measurement system analysis (MSA/GR&R) and specification reviews.
- Provide guidance on testing procedures and data collection methods.
- Maintain documentation and ensure adherence to Quality Management Systems (QMS) and regulatory requirements.
- Communicate effectively with customers and internal stakeholders to resolve quality issues and ensure satisfaction.
Required Skills & Qualifications
- Bachelor's degree in Engineering, Quality Management, or a related technical field.
- 3-5 years of experience in a quality engineering role, preferably within medical device or life sciences industries.
- Demonstrated expertise in IQ/OQ/PQ validation processes.
- Advanced proficiency in Minitab statistical analysis software (basic knowledge is not sufficient).
- Effective verbal and written communication skills, including a clear and professional speaking voice for customer-facing interactions.
- Familiarity with Plastic Injection Molding and pharma manufacturing is advantageous.
- Knowledge of GD&T (ASME Y14.5), project management principles, and time management tools.
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