Manufacturing Quality Assurance Specialist

2 months ago

Danbury, Connecticut, United States Arcmed Full time
Job Summary

We are seeking a highly skilled Manufacturing Quality Engineer to join our team at Arcmed. As a key member of our Quality team, you will be responsible for ensuring the highest quality standards in our manufacturing processes.

Key Responsibilities
  • Oversee the implementation of corrective actions, preventive actions, and containment procedures to ensure compliance with quality standards.
  • Collaborate with cross-functional teams, including Manufacturing, Operations, and Engineering, to identify and resolve quality issues.
  • Develop and implement quality control procedures to ensure the accuracy and reliability of our products.
  • Conduct training sessions to educate internal stakeholders on quality procedures and best practices.
  • Monitor and analyze key performance indicators (KPIs) to identify areas for improvement and optimize our manufacturing processes.
  • Represent the Quality department in product development teams and projects, working closely with Engineering and QA Manager to develop and execute quality plans.
  • Design and implement process validation and verification procedures to ensure the quality and reliability of our products.
  • Lead supplier corrective actions requests (SCARs) to ensure compliance with quality standards.
  • Interpret and apply geometric dimensioning and tolerancing (GD&T) principles to ensure accurate product design and manufacturing.
Requirements
  • Bachelor's degree in an Engineering discipline.
  • Knowledge of ISO 9001, ISO 13485, and other recognized international quality system standards.
  • Excellent analytical and problem-solving skills, with the ability to interpret technical procedures and regulations.
  • Strong communication and interpersonal skills, with the ability to present proposals and data to stakeholders at all levels.
  • Ability to work independently and as part of a team, with a strong focus on collaboration and teamwork.
  • Experience with Epicor and Microsoft Office applications, including Word, Teams, Visio, OneNote, PowerPoint, and Outlook.
  • Ability to operate media equipment, such as tablets and smartphones, and general office equipment.
  • Ability to work with and understand databases, with a strong focus on data analysis and interpretation.
About Arcmed

Arcmed partners with top Diagnostic and Analytical OEMs, Engineers, and Scientists to improve human health. We provide technology and supply chain solutions for the design and manufacture of precise fluid handling components for diagnostic and analytical instruments.

Our product portfolio offers configurable fluidic components and engineered systems used for precise reagent and sample handling in instrumentation for OEMs in the In-Vitro Diagnostic (IVD), Next Generation Sequencing (NGS), and analytical chemistry markets.

Arcmed offers labware and chromatography components to scientific laboratories in drug discovery and downstream biotech development workflows.

We are recognized as a leader in helping engineers, scientists, and doctors to solve the world's toughest diagnostic and analytical challenges.

Our Values
  • We always act with intention and drive to achieve our purpose.
  • Teamwork, collaboration, and diverse opinions make us stronger.
  • We are unafraid to make timely decisions, and we empower our people to make decisions, execute them, and move forward.
  • We value people who take the initiative and hold themselves accountable.
  • Challenging the status quo helps us grow. We look for and call out improvements.

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