BD · 4 months ago
Engineer II, Supplier Quality (Temporary), APM
BD is a company focused on critical care technologies, and they are seeking an Engineer II for Supplier Quality. This role is responsible for investigating and correcting quality issues with suppliers, conducting audits, and implementing strategies to enhance supplier management.
Health CareMedical DeviceTechnical Support
Responsibilities
Develop and maintain sampling methods and procedures for inspections, testing and evaluation. It supports Quality Operations to guarantee that the products and processes comply with the relevant requirements of the Quality Management System
Review and approve feasibility studies, process / product changes, technical reports, product transfers, market and clinical trial plans, and protocol reports
Work with a multifunctional team to support investigations of nonconformities to identify the root cause in a timely manner and recommend provision and corrective actions to avoid recurrence
Support activities related to the evaluation of product risks for non-compliant distributed products
Develop and support supplier audits
Maintain documentation related to the provider's quality system requirements
Work with product / process transfer projects to ensure compliance with the procedures, as well as the facilitation of the activities required in the transfers
Develop and support ongoing improvement activities to improve Quality Systems, using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, SPC, Kaizen Lean methods, DOE, etc
Other incidental duties
Qualification
Required
Bachelor's degree in engineering or Scientific field
2 years' experience, required or master's degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education, required
Good computer skills in usage of MS Office Suite including MS Project
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required (if applicable)
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Knowledge of applicable FDA regulations for medical device industry
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Preferred
CAD experience preferred (if applicable)
Company
BD
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Recent News
EIN Presswire
2026-01-09
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