Quality Engineer - Validation
Validation Engineer - Contract | Medical Device Manufacturer | North Carolina (Hybrid)
A leading medical device manufacturer in North Carolina is seeking a Validation Engineer for a contract position to support product development, validation, and quality assurance initiatives.
Position Summary:
This role applies quality engineering principles across all phases of the product lifecycle, including planning, development, and qualification/validation. The successful candidate will contribute to the deployment of quality strategies and ensure compliance with internal and external standards.
Key Responsibilities:
- Lead validation activities including protocol development and execution (IQ/OQ/PQ).
- Support new product launches using APQP methodologies.
- Analyze process and product performance data to assess capability and compliance.
- Collaborate with cross-functional teams to optimize manufacturing processes.
- Develop validation documentation in accordance with internal and customer requirements.
- Manage multiple programs and customer deliverables simultaneously.
Qualifications:
- Bachelor's degree in Engineering or a related technical field.
- Minimum of 3 years of experience in a similar role, preferably in medical or pharmaceutical manufacturing.
- Proficient in validation processes and statistical analysis (Minitab preferred).
- Experience with plastic injection molding and GD&T (ASME Y14.5) is desirable.
- Strong analytical, communication, and project management skills.
Additional Skills:
- Knowledge of measurement system analysis (MSA/GR&R).
- Familiarity with quality assurance tools and time management practices.
- Ability to work independently and collaboratively in a fast-paced environment.
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