QC Technician III, Lyra

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Business Enablement/Support

All Job Posting Locations:

Bridgewater, Massachusetts, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a QC Technician III, Lyra.

Purpose: This role is responsible for conducting technical quality assurance inspections of incoming materials, parts, and components against established standards and specifications before they are accepted into inventory. Inspection methods may include but are not limited to measurement of parts, visual inspection, and documentation review. The candidate will also be responsible for ensuring the accuracy and completeness of records related to the production and testing of medical devices, ensuring compliance with regulatory requirements and company procedures. This includes reviewing documentation, verifying data, and collaborating with other departments to resolve any discrepancies.

Qualifications:

• Perform routine product inspections and analyses, generally of finished goods, components, incoming materials, materials prior to be sent to external service suppliers, or new products, by observing, measuring, and recording data.
• Utilization of blueprint reading skills daily.
• Has general awareness of GD&T principles.
• Compares inspection results to defined requirements or specifications and documents differences found. Compiles and inputs data into router, logbook and/or computer databases and documents findings.
• Completes record of inspection results, acceptance, rejection, and disposition.
• Consults with more experienced personnel to confirm presence of non-conformances and subsequent product disposition.
• Executes assigned NR actions within the applicable software application.
• Compiles data to identify trends, prepares reports on findings, and proposes corrective actions.
• Recommends and implements revisions, corrections and changes to test equipment, procedures, and methods.
• Perform document change management as per local procedures.
• Initiates and coordinates discussions with quality, engineering, and other relevant departments to develop corrective actions for reoccurring problems.
• Provides external service suppliers with appropriate gages for calibration.
• Support broader quality efforts to assess impacted stock inventories (e.g., stock audits, stop shipments).
• Audits batch records to ensure compliance with policies, procedures, and regulations.
• Ensures batch records are complete and accurate, with all NC’s dispositioned prior to release.
• Stores and maintains batch files either physically or electronically based on established guidelines.
• Identifies, records and reports on batch non- conformances and product holds.
• Applies principles of Good Documentation Practices.
• Provides assistance in validation activities.
• Maintains training records up to date.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications / Requirements:

• A minimum of High School Diploma or equivalent is required.
• At least a year of relevant work experience is required.
• Excellent written, oral communication, organization and computer skills required.
• Quality-oriented mindset, adaptability, collaborative, service-oriented are also some of the required traits.
• Medical device inspection experience