Quality Engineer II

Becton Dickinson Medical Devices•Sparks, NV

22d•Onsite

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. General Responsibilities Engages with quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision. Ensure the plant/functional quality organization fulfills its obligations and aligns with applicable laws and procedures. Effectively navigate and help lead through the challenges of change and establish key stakeholder engagement focusing on solutions. Continuously evaluate progress toward tactical goals and objectives adapting them to meet customer and business needs. Development and implement best quality practices for areas of responsibility. Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards. Maintain positive and collaborative communication and collaboration with all levels of employees, customer, contractors, and vendors. Pursue and maintain a functional knowledge of global regulation affecting the local business. Demonstrate ability to influence without authority and deal effectively with ambiguity. Ability to develop solutions to assigned activities of low/moderate complexity. Strong communication, problem solving, organizational and interpersonal skills. Able to work self-direct by identifying and addressing risks within sphere of influence. Functional responsibilities: This role will have primary focus on PMS (Post Market Surveillance) activities- including, but not limited to customer complaints, CID/CAPA, SA/FA, Quality metrics and complaint data analysis. Responsibilities include monitoring, investigating and trending customer complaints for manufactured and distributed components/products. Assesses Critical to Quality (CTQ) parameters and risk assessment variables as part of the decision-making processes to support predictable product design and flow. Initiates and/or supports CAPAs and may lead the investigation/corrective action process. Initiates and/or supports Situation Analysis and/or Field action process. Initiates and/or supports change notifications (change controls). Responsible for the various aspects of IDAST QM Engineering as well as day-to-day QM Engineering responsibilities for assigned products and related operational area projects. Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems. May support both internal and external audits as a Subject Matter expert (SME). Is also responsible for assuring departmental compliance with ISO and FDA requirements participation on teams, assigned project support, product launches and process improvements, product quality notifications, and IVDR compliance. This includes using Enterprise tools to ensure compliance and streamline processes. Other duties as assigned based on business needs.

Requirements

Bachelor's degree in Engineering or Science
Minimum 3 yrs quality engineering experience.

Responsibilities

Engages with quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision.
Ensure the plant/functional quality organization fulfills its obligations and aligns with applicable laws and procedures.
Effectively navigate and help lead through the challenges of change and establish key stakeholder engagement focusing on solutions.
Continuously evaluate progress toward tactical goals and objectives adapting them to meet customer and business needs.
Development and implement best quality practices for areas of responsibility.
Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
Maintain positive and collaborative communication and collaboration with all levels of employees, customer, contractors, and vendors.
Pursue and maintain a functional knowledge of global regulation affecting the local business.
Demonstrate ability to influence without authority and deal effectively with ambiguity.
Ability to develop solutions to assigned activities of low/moderate complexity.
Strong communication, problem solving, organizational and interpersonal skills.
Able to work self-direct by identifying and addressing risks within sphere of influence.
This role will have primary focus on PMS (Post Market Surveillance) activities- including, but not limited to customer complaints, CID/CAPA, SA/FA, Quality metrics and complaint data analysis.
Responsibilities include monitoring, investigating and trending customer complaints for manufactured and distributed components/products.
Assesses Critical to Quality (CTQ) parameters and risk assessment variables as part of the decision-making processes to support predictable product design and flow.
Initiates and/or supports CAPAs and may lead the investigation/corrective action process.
Initiates and/or supports Situation Analysis and/or Field action process.
Initiates and/or supports change notifications (change controls).
Responsible for the various aspects of IDAST QM Engineering as well as day-to-day QM Engineering responsibilities for assigned products and related operational area projects.
Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems.
May support both internal and external audits as a Subject Matter expert (SME).
Is also responsible for assuring departmental compliance with ISO and FDA requirements participation on teams, assigned project support, product launches and process improvements, product quality notifications, and IVDR compliance.
This includes using Enterprise tools to ensure compliance and streamline processes.
Other duties as assigned based on business needs.