Quality Engineer II
Job Description SummaryThe Quality Engineer position provides quality engineering support for new and existing products to ensure that transferred designs and the associated manufacturing processes are safe and effective. The successful candidate will support safe and efficacious products through complaint and risk management, such as (i.e. trending, investigating, correcting and monitoring product issues and maintaining risks), and will be advocates for complying with company policies/procedures, government regulations and industry standards. This position supports product leadership and risk management of new product development.
- Leads development of risk assessments and test methods
- Supports component qualifications, design validation / verification and process validation
- Leads basic level product investigations
- Ability to make and present risked based decisions
- Assess product changes against product design
- Supports translation of design inputs into manufacturing control plans
- Quality Engineering representation on Product Development Teams.
- Participate and provide input to training on department/division procedures, and policies.
- Participate in project planning, budgeting, scheduling and tracking.
- Support internal and external supplier audits.
- Develop and implement procedures to comply with corporate and industry standards.
- Provide support to the regulatory department in writing technical submissions.
- Provide positive example and actively promote compliance to division, corporate and industry standards.
- Maintain a professional working relationship with internal and external customer and support staff.
- Prepare and present project updates and technical discussions.
- Support "Voice of the Customer" identification and translation into design inputs.
- Knows how products are used and impact the user(s) so that risk can be managed effectively.
- Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)
- B.S. in Engineer or Tech Science
- 3.5 years-relevant experience
- Working knowledge in some of the related business technologies.
- Ability to develop solutions with moderate business impact.
- Advanced statistical and risk assessment techniques.
- Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies.
- Working knowledge of code level review, software logic review, black box testing, and system validation.
- Ability to make and present risk based decisions
- Strong interpersonal skills
- Ability to analyze and optimize manufacturing and quality systems
- Product, design & prototyping
- Ability to create and provide training
- Software application skills
- Problem solving ability
- Ability to create, review and coordinate test protocols and reports
- Ability to generate engineering proposals
- Oral and written presentation skills
- Ability to Lead cross functional teams
- Understanding of regulatory requirements
- Ability to lead creation of risk management files
- Ability to translate Voice of the Customer to Design Requirements and then to Manufacturing control plans
- Prefer a minimum of five years experience in the medical field or closely related industry or Masters Degree plus two years
- Quality Engineering Certification (ASQ) or equivalent.
- Working knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO
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, or any other protected status.
Primary Work LocationUSA AZ - Tempe Headquarters
Recommanderà un ami
Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ