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Senior Quality Assurance Specialist
2 months ago
Position Overview:
A prominent contract manufacturing firm specializing in injection molding is seeking a Lead Quality Assurance Engineer. This role requires a dedicated professional to work onsite, ideally with a background in plastic injection molding.
Essential Qualifications:
- Bachelor's degree in engineering or a related discipline, or equivalent experience in a contract manufacturing setting, preferably within regulated sectors.
- A minimum of 8 years of experience in quality assurance engineering.
- Proficiency in medical devices, plastic injection molding, and/or contract manufacturing.
Key Responsibilities:
- Collaborate effectively with team members across various departments.
- Act as the quality representative on cross-functional teams focused on new product development.
- Review all relevant documents and specifications associated with drawings or purchase orders, identify issues, and communicate findings to the development team. Facilitate necessary changes to drawings and specifications to ensure successful project transitions to production.
- Proactively assess customer and project needs, devising strategies to mitigate potential risks throughout the project lifecycle.
- Respond promptly and professionally to quality-related inquiries from both internal and external customers.
- Comprehend and adhere to regulatory standards set by the FDA, ISO, and other governmental bodies.
- Design and refine validation protocols, executing reports to satisfy regulatory, customer, and internal production criteria.
- Create inspection plans, tools, and methodologies to meet quality standards, documenting any quality concerns during development to ensure best practices are upheld.
- Coordinate with the metrology team to plan and conduct product first article inspections, capability studies, and gage R&Rs, ensuring data accuracy for customer submissions.
- Investigate and analyze the root causes of product quality issues and defects for new products, implementing corrective measures as necessary; assist colleagues with the corrective action process.
- Establish and prioritize tasks for multiple projects of varying complexity to meet customer expectations aligned with new product development timelines.
- Drive continuous improvement in procedures, processes, workflows, and compliance with standards to enhance product quality.
- Provide expertise and support to Sustaining Engineers, addressing production challenges as needed.
- Conduct internal audits as per the established audit schedule.
- Mentor and guide less experienced team members on quality and project-related matters, fostering their professional growth and ensuring timely resolution of issues.
- Identify gaps and propose solutions regarding existing equipment, resources, and technology to ensure the quality team is equipped to meet evolving market and customer demands.
Compensation Range: $95,000 - $140,000
