BD (Becton, Dickinson and Company) Sr. Quality Engineer in Salt Lake City, Utah
This position develops implements and improves new and existing product quality requirements.
This position will assist with complaint investigations, quality management remediation efforts and other quality engineering activities as required.
Provide Quality Engineering representation on Product Development Teams.
Initiate new or revised documentation
Lead cross-functional teams to develop risk assessment.
Develop physical and functional test methods to ensure specifications are met.
Write, review and approve design verification and validation protocols and reports.
Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
Conduct and /or coordinate testing outlined in protocols and test methods.
Perform process improvement, control and monitoring on manufacturing processes.
Provide technical direction during design transfer activities.
Conduct complaint investigations.
Participate and provides input to training on department/division procedures, and policies.
Coordinate and lead internal and supplier audits.
Develop and implement procedures to comply with corporate and industry standards.
Understand and follow company procedures on regulatory requirements.
Provide support to the regulatory department in writing technical submissions.
Provide positive example and actively promotes compliance to all standards.
Maintain a professional working relationship with internal and external customer and support staff.
Prepare and present project updates and technical discussions.
Ability to make and present engineering decisions
Strong interpersonal skills
Demonstrated Project Management skills
Understanding and application of DOE
Ability to lead cross functional teams
Engineering cost analysis
Ability to analyze and optimize manufacturing and quality systems
Advanced product, design & prototyping skills
Ability to create and provide training
Software application skills
Advanced problem solving skills
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
Oral and written presentation skills
In-depth knowledge of regulatory requirements
Ability to develop and control a budget
Ability to manage technical personnel
Ability to perform design review functions
Must read, write and understand English.
Must be detailed in handling information/data.
Prefer a minimum of 6 years’ experience in the medical field or closely related industry or a Master’s Degree plus three years. Quality Engineering Certification (ASQ) or equivalent. Extensive knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.
Career Level: experienced
Relocation Available?: No
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 605 N. 5600 W.
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.