BD (Becton, Dickinson and Company) Senior Quality Engineer in Salt Lake City, Utah
Job ID: 2018-12434
Career Level: experienced
Location: Salt Lake City,Utah,United States
BARD has now joined BD, a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Vascular Access Devices, a sub-business unit of Medication Delivery Solutions, focuses on developing, manufacturing, and distributing high-quality medical devices used by clinicians throughout the worldwide healthcare industry to access a patient’s vasculature. Our devices assist in the delivery of chemotherapy, blood products, antibiotics, and nutrition.
Summary of Position with General Responsibilities:
This position is responsible for system development and improvement along with managing projects with divisional impact.
Essential job Functions:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
Consultant/Division expert; Division Technical expert
Develops Innovative ideas for the organization
Broad business and technical understanding
Influences and directs others across organization; Coach/Mentor
Critical Decision Maker in areas of engineering and business needs
Project Leader; Representative of BAS
Initiates new or revised documentation and tracks through appropriate approval cycles and implementation
Maintains a professional working relationship with internal & external customer and support staff
Participates and leads cross-functional teams and/or projects
Provides technical support on components, material methods, systems, processes and/or equipment
Develops physical and functional test requirements to assure specifications & regulations are met
Writes and approves protocols, reports and data
Manages testing outlined in protocols and test methods
Manages/develops validation studies on equipment & processes
Conducts and/or supports product complaint investigations
Understands and follows company procedures and regulatory requirements
Participates in and provides input to training on department & division procedures, and policies
Manages project planning, budgeting, scheduling and tracking
Analyzes problems in design, process, and/or test development. Recommend/implement solutions
Prepares and presents oral and written project updates and technical discussions
Develops and implements procedures/policy
Develop sampling plans by applying attribute, variable, and sequential sampling methods
Develop local procedures, Test Methods, and standards
Develop and implement Statistical Process Control
Leads investigations related to quality problems
Ability to define and manage risk-management plan, risk assessment and risk-control tools
Independently lead or facilitate non-conforming product investigations, including corrective/preventive actions and product remedial actions
Responsible for systems assurance including documentation, testing and inspection, and product and process development
Will support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure systems are in compliance with internal and external guidelines and regulations
Proficient in statistical analysis and software
Identify and lead product and systems continuous improvement initiatives
Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary
Able to influence decisions in a cross-functional team setting
May supervise the efforts of a direct report
Participate in collecting/developing and analyzing design inputs
Equipment Qualification Experience (IQ/OQ/PQ)
Acts as a Division level Subject Matter Expert (SME)
Execute design controls and analyzes design inputs
May support or lead internal/external audits
Education and/or Experience:
This position requires:
A Bachelor’s degree in STEM and six (6) years of engineering experience within a regulated industry, OR
Masters degree in STEM and four (4) years of engineering experience within a regulated industry.
Preferred Qualifications Include:
Experience in medical device industry strongly preferred.
Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills.
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. The incumbent may be required to stand for extended periods of time. Bending, stooping and reaching are also frequently required.
The ideal candidate must be able to work in a team oriented, fast paced environment. Bard Access Systems is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status