BD (Becton, Dickinson and Company) Sr Quality Engineer in Sandy, Utah
Job Description SummaryAs directed by the Quality Manager, the Sr Quality Engineer 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.
As directed by the Quality Manager, the Sr Quality Engineer 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.
Primary Responsibilities and Dutie s
-Extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measureable / confirmed results.
-Track record of root cause determination and effective corrective / preventive action implementation.
-Provides training for product development teams and continuous improvement team on best practices.
-Conducts audits as member of a quality system audit team (e.g. SME, etc.)
-Writes and leads risk management activities including risk management reports and risk analyses.
Position-Specific Overview: Position specific responsibilities include support of the following, however are not limited to:
-Design Verification plans, protocols, and reports
-Design History File support
-Assessment of Change Request (ACR) Responses
-Identification of CTQ's
-Unit Quality Independent Reviewer During Design Reviews
-Handling of deviations and non-conformances
-Test method validations
-Post Market Surveillance
-CAPA – Root cause investigation and implementation of corrective / preventive actions
-Proper Use of Statistics (Sampling Plans)
-Advise on Regulations
-Liaise with Manufacturing Plants
-Provide functional support to cross-functional teams
-Internal and external audits
Strategic Orientatio n:
-Guides the successful completion of major programs and may function in a project leadership role.
-Ensures quality conduct of projects, including design, data summary and interpretation, report 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
Sphere of Influence:
-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 core team or extended core team member
Extensive knowledge of applicable regulatory, Corporate and / or Unit requirements.
Training in design of experiments and statistics.
4 years Class II / III medical device experience.
Knowledge of six sigma methodology preferred.
Knowledge of design control principles (preferred).
Ability to support internal / external audits.
Requires a minimum of a Bachelor’s Degree Chemical, Electrical, Mechanical or Biomedical Engineering
Certified Quality Engineer and Certified Quality Auditor (preferred).
Primary Work LocationUSA UT - Sandy
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