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Lead Quality Assurance Engineer
2 months ago
Position Overview:
A prominent contract manufacturing and injection molding organization is seeking to appoint a Senior Quality Engineer. This role requires a quality expert who will work entirely onsite and ideally possesses 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, particularly in regulated sectors.
- A minimum of 8 years of experience in quality engineering.
- Familiarity with medical devices, plastic injection molding, and/or contract manufacturing.
Key Responsibilities:
- Collaborate effectively with all team members in a cooperative environment.
- Act as the quality representative on cross-functional teams focused on new product development.
- Review all documentation and specifications related to drawings or purchase orders, identify potential issues, and communicate these to the cross-functional team. Drive necessary changes to drawings and specifications to facilitate project transitions to production.
- Proactively lead and anticipate customer and project needs, developing strategies to mitigate risks encountered during project execution.
- Respond promptly and professionally to internal and external customer inquiries related to quality.
- Understand and adhere to regulatory requirements for FDA, ISO, and government standards.
- Develop and refine validation protocols and execute reports to satisfy regulatory, customer, and internal production standards.
- Create inspection plans, fixtures, and methodologies to meet quality requirements and standards, documenting quality issues identified during development to ensure best practices are followed.
- Work closely with the metrology team to schedule and conduct product first article inspections, capability studies, gage R&Rs, etc. Analyze data to ensure accuracy for customer submissions.
- Investigate and identify root causes of product quality issues and defects for new products, implementing solutions to resolve these issues; assist other personnel with the Corrective Action process as needed.
- Establish and prioritize tasks for multiple programs of varying complexity to meet customer expectations based on new product development timelines set by the program management team.
- Drive continuous improvement in procedures, processes, workflows, compliance with standards, and overall product quality.
- Provide project knowledge and insights to Sustaining Engineers and support production issues as required.
- Conduct internal audits as necessary, following the internal audit schedule.
- Mentor and guide less experienced team members regarding quality and project-related matters to foster personal and professional growth, ensuring timely and effective resolution of issues.
- Proactively identify gaps and potential solutions in existing equipment, resources, and technology to ensure the quality team is well-equipped to meet evolving market and customer demands.
Compensation Range: $95,000 - $140,000
