BD (Becton, Dickinson and Company) Staff Quality Engineer in Vestavia Hills, Alabama
Job Description SummaryWe have an immediate opening for a highly motivated, results-focused professional to join our team as a Staff Quality Engineer. The primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, create verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation, support creation of 510k packages, conduct failure\problem investigations, identify system issues, summarize findings and prepare reports for key quality metrics. Responsibilities also include being the quality and compliance representative in the assigned teams.
Responsible for being the prime quality representative for design control projects – new product development as well as sustaining efforts.
Responsible for review and/or approval of design history file documentation in support of design controls.
Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory, compliance and product security support.
Writes and/or leads risk management activities including risk management reports and risk analyses.
Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
Works together with SW Quality Engineers to ensure effective verification of design specifications and/or requirements.
Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).
Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.
Active participant in the development of product requirement, product system hazard analysis and design reviews.
Work closely with Product Management to ensure effective validation of user needs.
Ensure product technical files and Design History Files are complete and auditable.
Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
Conducts audits as member of a quality system audit team (e.g. SME, etc.)
Track record of root cause determination and effective corrective / preventive action implementation.
Provides decisions, recommendations, and results to further the achievement of goals critical to organizational objectives.
Identifies areas requiring quality improvement and initiates and follows through plans of action (Quality Plans) necessary for implementation.
Quality lead in 510k or International submissions.
Successful completion of major programs/initiatives and may function in a project leadership role.
Mentor to Quality Engineers on approach to design controls, agile design, risk management and product security. When applicable, have the ability to manage quality engineers.
Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams
What is expected of you for success in your role
Communicates effectively with cross-functional and execute team’s objectives.
Excellent organizational skills to effectively manage several projects in parallel.
Ability to quickly learn, understand and comprehend highly technical concepts.
Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measureable / confirmed results.
Uses analytical thinking and reasoning to anticipate implication/conclusions of a complex situation or issue.
Makes tough decisions that impact the program, team, or individuals, while supporting decisions with clearly communicated rationale.
Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
Excellent understanding of design controls and risk management methodologies.
Excellent understanding on translation of voice of customer input to requirements.
Teamwork oriented and ability to lead and influence without authority
Able to work with minimum supervision.
Interprets internal and external business issues and adapts work priorities accordingly.
Able to train Quality Engineers on overall quality approach to design controls.
Bachelor's degree in engineering or life sciences.
10+ years related experience in design and development.
ASQ certified (CQA, CQE, CSQE, CMQ) is a definite plus
Must be able to apply quality principles (ISO 13485, IEC 62304, 21 CFR, etc.) to the R&D environment
In-depth knowledge of software development life cycle and test methodology.
Experience dealing with SW only products highly desired
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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
Primary Work LocationUSA AL - Birmingham - Vestavia
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.