BD (Tissuemed Ltd) · 1 week ago
Senior Principal Quality Engineer
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $206K/yr
8+ years expBD (Tissuemed Ltd) is one of the largest global medical technology companies, dedicated to advancing health through innovative solutions. The Senior Principal Quality Engineer will apply quality engineering principles to ensure compliance with regulatory requirements and optimize product development and device manufacturing processes.
Health CareHospitalMedicalMedical Device
Responsibilities
Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
Own and close complaint Engineering investigations for BD electronic complaints
Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement; find opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Develop, update, and maintain technical content of risk management files for NPD and existing products
Develop training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes
Support product upgrading and reworking tasks as needed as Quality Engineer
Assign support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work
Train, coach, and guide lower-level employees on routine procedures
Other incidental duties assigned by Leadership
Qualification
Required
Bachelor's Degree in Engineering or Scientific field
Minimum of 8 years experience, including strong electromechanical medical device experience
CAPA and complaints management experience required
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Strict attention to detail
Preferred
ASQ Certified Quality Engineer (CQE)
Considers the cause and effect of activities
Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment
Determines or effectively recommends course of action after considering potential risks of alternatives by comparing and evaluating possible courses of action after considering various possibilities
Works independently without close supervision
Applies their knowledge in following procedures or in determining procedures to follow or determining whether specified standards are met
Proven expertise in usage of MS Office Suite
Ability to read and interpret drawings
Proven expertise in statistical techniques
Ability to translate complex and technical information to all levels of the organizations
Recognized as an expert in own area within the organization
Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Expertise of Six Sigma concepts with the ability to lead projects applying these principles
Expertise in applying Quality Engineering concepts (e.g., CQE body of knowledge) with the ability to lead projects using these principles
Advanced problem-solving, organizational, analytical and critical thinking skills
Expert understanding of processes and equipment used in assigned work
Strong leadership skills and ability to influence change and challenge status quo with respect to opportunities for improvement
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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