- Guides the successful completion of major programs and may function in a project leadership role.
- Provides management with review opportunities at key points and upon completion
- Ensures quality conduct of projects, including design, data summary and interpretation, report and manuscript preparation and review adherence to applicable regulations
- Decisions, recommendations and results further the achievement of goals critical to organizational objectives
- Implements and communicates the strategic and technical direction for the product/project team
- Identifies any issues that may delay product or project and recommends appropriate action to be taken.
- Works under consultative direction toward predetermined long-range goals and objectives.
- Creates and supports documentation
- Considered Site / functional level Subject Matter Expert.
- May be assigned as site / functional extended team member
- Provides mentoring / coaching for application of technical principles, theories, concepts and quality, tools and systems.
- Develops technical solutions to complex problems which require the regular use of ingenuity and creativity.
- Is a core team member for complex design control / process control projects.
- Is a CAPA expert
- Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.
- Supports and can lead quality system audits.
- Provides input to management review process
- May perform other duties as required
- Support the implementation of new products, processes, and changes by developing quality plans, approval/development of design verification and design validation plans and protocols, inspection methods, work instructions, and raw material specifications and inspection plans. Extensive knowledge of Design Control Requirements.
- Extensive knowledge of Design Control Requirements.
- Analyze and interpret inspection and process data to identify and prevent quality problems and continuous improvement opportunities.
- Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material.
- Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints.
- Support manufacturing and quality process improvement projects as an effective team member or leader using Continuous Improvement and Six Sigma tools.
- Develop working knowledge of applicable regulatory, Corporate and/or Unit requirements.
- Conduct Internal and Supplier Audits. Provide audit support for customer and regulatory audits (preparation, closure, etc.)
- Communicates across functions / departments for assigned areas of responsibility.
- Comply with all local, state, federal, and BD Safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
- Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- May supervise Quality Engineering and Technician activities.
- Extensive knowledge of design control principles
- Extensive knowledge of applicable regulatory, Corporate and / or Unit requirements.
- Hands on experience in design of experiments and statistics.
- Strong understanding and application of six sigma methodology (preferred)
- Class II / III medical device experience
- Typically requires a minimum of a Bachelor's Degree
- A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.
- Certified Quality Engineer (preferred)
- Certified Quality Auditor (preferred)
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Staff Quality Engineer I - Sandy, United States - BD (Becton, Dickinson and Company)
Description
Job Description Summary
As directed by the Quality Manager, the Staff Quality Engineer I is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices.
This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
Job Description
We are
the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM 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 amaker of possible with us.
STRATEGIC ORINETATION
SPHERE OF INFLUENCE
PRIMARY RESPONSIBILITIES
POSITION "SPECIFIC" OVERVIEW
SUPERVISION
EDUCATION AND EXPERIENCE REQUIREMENTS
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.
In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visit om/careers
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.
PDN
Primary Work Location
USA UT - Sandy
Additional Locations
USA UT - Salt Lake City
Work Shift
NA (United States of America)
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.
