BD (Becton, Dickinson and Company) Senior Quality Engineer in Tempe, Arizona
Job Description Summary
Becton, Dickinson Interventional (BDI) 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 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare. BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer. 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, respect, and feel valued, acknowledged and rewarded. Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world.
This position develops implements and improves new and existing product quality requirements.
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.
A minimum of a Bachelors degree in a technical field
Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters Degree plus three years.
Quality Engineering Certification (ASQ) or equivalent.
Extensive knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.
Primary Work LocationUSA AZ - Tempe BPV Building 3
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