Quality Assurance Laboratory Technician - Nights | Layton, UT

Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.

testing strategies, design fixes, and patches. Perform system load tests for new products. Manage and train apprentices, junior testers, and new developers. Work with other quality technicians to document the quality processes for replication in other locations.

Manage testing projects during each phase, according to the Software Development Life Cycle (SDLC). Make improvements to functionality, design, and usability of new products.

Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.

of our billions of Med Tech 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. As directed by the Quality Manager, the Senior Quality Engineer will be a member of the Advanced Access Devices (AAD) platform and is accountable for product maintenance and new product development through the application of Quality engineering skills for medical devices. This person will handle projects

and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Responsibilities: Provide guidance and Quality oversight to ensure establishment and execution of robust design control programs aligned with regulatory requirements and industry standards. Support new product development and existing product sustaining activities to ensure work follows proper designcontrol. Ensure controls meet BD and FDA regulatory requirements by actively participating on product developmentteams

and identifying Quality needs, product improvements and customer requirements.

Ensures adequate design control documentation and records are maintained to support life cycle of design history. Support new product development execution of design control and ensure tasks are completed adequately to include projectplanning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, anddesign history files and other activities as needed. Provide guidance and training to cross-functional associates to help increase knowledge of regulations andstandards for Devices and Combination Products. Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers anacceptable quality level during manufacturing with properly established product specifications.

Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk. Review and authorize Quality approval for new product and/or device design specifications including productperformance specifications, test methods, acceptance criteria, and release. Review and backss work performed by R&D and other BD business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.

Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and Process Validation. Lead or participate in ISO 14971Risk Management activitiesappropriate to the initiative or situation. Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customerinput. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Field Assurance, Manufacturing, Engineering, Regulatory and Biostatics.

Initiate Corrective and Preventative Action plans and perform efficacy follow up. Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD andregulatory requirements. Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPsand established Quality Systems. Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. Support regulatory inspections as needed. Lead investigation and Field activities relating to Field Corrective Actions, when needed.

Qualifications: Bachelor's degree in STEM and six (6) years of engineering experience, OR Master's degree in STEM and four (4) years of engineering experience required. Design Controls, Risk Management and Change Controls is required. Experience in medical device industry is required. American Society of Quality (ASQ) certification (CQE, CQA, etc)preferred. Experience with drug-device combination products is strongly preferred. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.

In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.

We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN Primary Work Location USA UT - Salt Lake City Additional Locations Work Shift Apply Save Job Responsibilities Job Description Summary Job Description 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 Med Tech 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. As directed by the Quality Manager, the Senior Quality Engineer will be a member of the Advanced Access Devices (AAD) platform and is accountable for product maintenance and new product development through the application of Quality engineering skills for medical devices.

This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Responsibilities: Provide guidance and Quality oversight to ensure establishment and execution of robust design control programs aligned with regulatory requirements and industry standards.

Support new product development and existing product sustaining activities to ensure work follows proper designcontrol. Ensure controls meet BD and FDA regulatory requirements by actively participating on product developmentteams and identifying Quality needs, product improvements and customer requirements. Ensures adequate design control documentation and records are maintained to support life cycle of design history. Support new product development execution of design control and ensure tasks are completed adequately to include projectplanning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, anddesign history files and other activities as needed.

Provide guidance and training to cross-functional associates to help increase knowledge of regulations andstandards for Devices and Combination Products. Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers anacceptable quality level during manufacturing with properly established product specifications. Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.

Review and authorize Quality approval for new product and/or device design specifications including productperformance specifications, test methods, acceptance criteria, and release. Review and backss work performed by R&D and other BD business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues. Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and Process Validation.

Lead or participate in ISO 14971Risk Management activitiesappropriate to the initiative or situation. Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customerinput. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Field Assurance, Manufacturing, Engineering, Regulatory and Biostatics. Initiate Corrective and Preventative Action plans and perform efficacy follow up. Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD andregulatory requirements.

Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPsand established Quality Systems. Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. Support regulatory inspections as needed. Lead investigation and Field activities relating to Field Corrective Actions, when needed. Qualifications: Bachelor's degree in STEM and six (6) years of engineering experience, OR Master's degree in STEM and four (4) years of engineering experience required. Design Controls, Risk Management and Change Controls is required.

Experience in medical device industry is required. American Society of Quality (ASQ) certification (CQE, CQA, etc)preferred. Experience with drug-device combination products is strongly preferred. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive.

And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA UT - Salt Lake City Additional Locations Work Shift Apply Save Job PDN-9ae5d82b-c622-4bdb-a92e-2963cdbb7aa9