Quality Engineering Assistant - Process

BD • Broken Bow, NE

191d

About The Position

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. The primary responsibilities of the Quality Engineering Assistant - Process are in alignment of those with a quality shift lead. The position will flow to work as instructed by quality management in the areas of Quality Engineering and Incoming Inspection. Determines final release of product leaving Broken Bow, reviews device history records for complete and proper documentation for meeting product requirements to release. Supports inventory control of product on hold. Monitors production processes and product quality and makes decisions regarding the acceptability of in-process and finished product. Maintains and manages the record QA retentions area. Supports special project activities, Factory Work Orders (FWO's) and process/product validations. This role is utilized as a source of critical information for scheduling, sterilization, production, and shipping.

Requirements

• Associates degree or commensurate experience required.
• Bachelor's degree strongly preferred.
• Two years of quality control/quality assurance experience required.
• Previous experience with inspecting and/or verifying the quality of products preferred.
• Experience in execution and understanding of validation protocols strongly preferred.
• Previous experience in writing of validation, study, and MSA protocols strongly preferred.
• Previous experience in SOP creation or update and approval collection is required.
• Strong verbal, written and analytical skills.
• Ability to use all basic mathematical operations.
• Experience using Minitab strongly preferred.

Responsibilities

• Determines the final release status of finished product.
• Completes necessary documentation and identifies product as being released.
• Reviews DHR's for proper documentation and inputs necessary data in SAP.
• Functions as a trainer on how to complete appropriate functions of Batch Final Packer functions.
• Assists in training production associates on revised procedures and forms.
• Completes Material Review Notices, scrap memos, certifications and statistical sampling.
• Communicates effectively with all levels of Plant personnel to report product quality issues.
• Interfaces with inspection personnel to facilitate effective inspection and coordinate product flow.
• Reads and interprets product specifications and current standards to determine inspection requirements.
• Conducts device history and procedural audits as directed by QA Management.
• Performs incoming and final inspections as required.
• Conducts special sampling and product testing.
• Supports collection of data to monitor product quality trends and defect notifications in SAP.
• Assists in revising specifications, policies, procedures, and forms as necessary.
• Sets up and conducts experiments to provide meaningful data for analysis.
• Runs Factory work Orders and performs product testing for new or redesigned products.
• Conducts Process Capability Studies and MSA's, collecting, organizing and processing data.
• Provides support for internal audits, third party regulatory audits and customer complaints.

Benefits

• A career at BD means being part of a team that values your opinions and contributions.
• Encouragement to bring your authentic self to work.
• A culture in which you can learn, grow, and thrive.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Education Level: Associate degree