First Article Inspector

We are seeking a highly motivated First Article Inspector to join our Quality Control Team. The primary responsibility will include inspecting raw materials, processes, and products to ensure compliance with established quality standards and regulations. This role will also involve implementing quality management actions, contributing to the development of company policies, and providing quality support to projects from planning to completion.

To succeed in this role, candidate must ensure that materials, processes, and procedures meet regulatory and quality standards while swiftly resolving any discrepancies or issues that arise.

Key Responsibilities:

Perform quality testing and inspections to meet organizational standards

Promote cleanliness and ensure safe working conditions for the staff

Focus on corrective actions to ensure products meet required specifications

Maintain all documentation for auditing purposes

Collaborate with the Quality Control Manager regarding product and production information

Report bottlenecks and quality concerns to the Quality Control Manager Participate in quality calibrations and internal audits professionally

Stay updated on job knowledge by reading technical publications and attending seminars

Mentor and lead lower-level employees effectively

Ensure measuring equipment is properly functioning and request repairs when necessary

Approve finished products for final release and shipment

Collaborate with government agencies during inspections to maintain high production standards

Work with management and production teams to ensure quality products are produced

Ensure no expired raw materials are used in production

Assist in reviewing and updating quality control policies

Work as part of the team under the guidance of the Quality Assurance Manager Support the investigation and resolution of customer complaints and feedback

Remove defective products discovered during the production process

Monitor each production stage to prevent defects

Write and submit reports to the Quality Control Manager Conduct and record test results as required

Familiar with the Engineering Change Request/Order (ECR/ECO) process

Recommend modifications to existing production standards based on available equipment capacity and capabilities

Proficient in Microsoft Word and PowerPoint, with the ability to manage files and records effectively

In-depth understanding of medical device manufacturing processes and methods

Excellent interpersonal and communication skills, including the ability to teach and explain methodologies

Knowledgeable in quality processes and familiar with statistical techniques

Strong attention to detail, ensuring nothing is overlooked

Familiar with measurement and test equipment

Ability to work effectively in a team Knowledge of relevant regulations and quality control standards

Ability to interpret instructions in written, spoken, or diagram form Strong problem-solving skills

Education and Experience:

2+ years of experience working with quality systems, preferably in medical devices

Ability to inspect various materials (metal, plastic, electronics)
Experience reading blueprints and technical documents

Proficient in using inspection equipment (calipers, micrometers, optical comparators)
Proficient in Microsoft Office and quality management systems

Strong decision-making and problem-solving abilities

Excellent communication, interpersonal, and public speaking skills

Strong organizational skills

Schedule:

M-F; standard business hours + OT Opportunities Occasional Saturdays based on company needs

If you are passionate about ensuring high-quality standards and have the skills required for this role, we encourage you to apply for this exciting opportunity.
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