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Senior Quality Assurance Engineer
2 months ago
Job Overview
The Senior Quality Assurance Engineer plays a vital role within the New Products Development Team, overseeing quality assurance-related research and development activities from initial research through to product launch. This position is crucial in ensuring that quality engineering principles are integrated into both new product development and ongoing engineering projects.
Key Responsibilities
- Act as the primary quality representative for design control initiatives related to new product development and sustaining projects.
- Oversee all quality aspects of the design control process, including quality planning, verification and validation planning and execution, risk management, and regulatory compliance support.
- Provide guidance and clarification to teams regarding the overall quality system, with a focus on design controls.
- Collaborate closely with Program Managers to ensure that design deliverables are achieved and can be released for limited or general commercial availability.
- Work alongside Quality Engineers to ensure effective verification of design specifications and requirements.
- Monitor daily activities to ensure adherence to company policies and procedures, including compliance with quality management systems and relevant medical device regulations.
- Identify opportunities for quality improvement and initiate action plans for implementation.
- Participate actively in the development of product requirements, system hazard analyses, and design reviews.
- Engage proactively with partners to build consensus and resolve issues promptly.
- Provide statistical support and analytical problem-solving expertise for product development and manufacturing processes.
- Ensure that product technical files and Design History Files are comprehensive and auditable.
- Drive continuous improvement initiatives by facilitating collaboration with cross-functional teams.
Qualifications for Success
- Strong knowledge of quality engineering policies, principles, and best practices.
- Understanding of regulatory and international standards, including 21 CFR 820, ISO 13485, and ISO 14971.
- Comprehensive knowledge of the product development lifecycle.
- Familiarity with hardware, software, and firmware development processes.
- Ability to identify risks and work with program teams to document and develop mitigation plans.
- Proficient in applying Quality Engineering tools and practices such as Sampling Plans and Root Cause Analysis.
- Ability to work independently with minimal supervision and determine work priorities.
- Excellent verbal communication and interpersonal skills, with a proven ability to work effectively in a team environment.
- Proficiency in Microsoft Excel, Word, and other business systems.
- Preferred qualifications include Six Sigma certification and Quality Engineering Certification (ASQ) or equivalent.
Why Consider This Opportunity?
A career with BD offers the chance to be part of a team that values your contributions and encourages you to bring your authentic self to work. The culture fosters collaboration, accountability, and continuous improvement, allowing you to make a meaningful impact in the field of health.
