2nd Shift Quality Tech 2

BD-posted about 1 year ago

Full-time • Entry Level

Plainfield, IN

Miscellaneous Manufacturing

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The Quality Technician will support the Manufacturing Operations in the Medical Systems Division of BD by performing quality control activities on medical devices throughout all production stages. This role involves conducting inspections, generating quality data reports, and assisting in the investigation of non-conformances, ensuring compliance with quality standards and regulations.

Monitor assigned quality system performance through established metrics and/or quality objectives.
Address underperformance and escalate with appropriate leadership as needed.
Collaborate with functional process owners to train, mentor, and facilitate QMS requirements and continuous process improvement.
Maintain awareness of and follow applicable corporate quality procedures.
Act as a Subject Matter Expert (SME) for quality systems, ensuring compliance with storage and distribution processes.
Ensure the site meets the terms and obligations of local wholesale drug licenses as the designated representative.
Assist in times of urgency, breaks, absences, or vacation by becoming knowledgeable of the responsibilities of other positions.
Perform real-time visual inspections at the process level.
Generate quality data reports and distribute them to appropriate personnel.
Assist in investigating non-conformances identified through the manufacturing process.
Provide feedback to the Production Department regarding quality issues affecting manufacturing operations.
Maintain accurate records of quality data generated during inspections or testing of products.
Communicate information concerning product quality to management and other departments as needed.
Prepare, package, sterilize, and ship specimens.
Work safely within established guidelines.

Experience in a manufacturing environment preferred.
Knowledge of FDA regulations related to medical device manufacturing.
Working knowledge of Microsoft Office software including Word, Excel, PowerPoint, and Outlook.
Ability to work independently and as part of a team.
Strong organizational skills.
Good communication skills.
Problem-solving skills.
Ability to make decisions and solve problems.
Ability to communicate technical material to both technical and non-technical people.
Ability to read blueprints and specifications.

Collaborative work environment that fosters creativity and innovation.
Opportunities for professional growth and development.
Support for work-life balance with flexible work arrangements.

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