About the position
The Sr. Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that design controls and risk management principles are applied to new product development and sustaining engineering projects. This position also supports broader QMS activities (Audit, CAPA, Data Analysis, Installation & Servicing, Complaint Handling, etc.). We have an immediate opening for a highly motivated, results-focused professional to join our team, and are growing our staff as a Sr. Quality Engineer. The Quality Engineer's primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, review design artifacts, participate in risk analysis activities, collaborate on product development deliverable documentation, support failure investigations, identify system issues, summarize findings and prepare reports for key quality metrics. Please note this role is in the Quality organization and has no direct responsibility for software testing (V&V).
Responsibilities
- Responsible for being the core team quality representative for design control projects – new product development as well as sustaining efforts.
- Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
- Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
- Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval.
- Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets.
- Ensures effective verification and validation of design specifications and requirements.
- Reviews and ensures complete and comprehensive traceability of related design artifacts.
- Active participant in the development of product requirement, product system hazard analysis and design reviews.
- Proactively engage partners to drive consensus and resolve issues in a timely fashion.
- Works collaboratively to drive root cause analysis of failures and structured problem solving for product development and manufacturing issues.
- Ensure product technical files and Design History Files are complete and auditable.
- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams.
Requirements
- Bachelor’s degree in a relevant degree field (engineering).
- Minimum 3 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls.
- Strong knowledge of quality engineering policies, principles and best practices.
- Understanding of regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304.
- Comprehensive knowledge of software quality concepts within the software development lifecycle.
- Ability to identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place.
- Proficiency in Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.).
- Attentiveness to details with strong organizational skills.
- Ability to work proactively and independently.
- Ability to manage multiple priorities and be efficient in time management.
- Excellent verbal communication and interpersonal skills with the ability to work in a team environment.
- Proficiency in Excel, Word, and other desktop/general business systems.
Nice-to-haves
- Software development experience within a regulated environment.
- Strong background in software development methodologies.
- Experience working in an iterative development environment like Scaled Agile Framework (SAFe) esp SAFe Certifications.
- Thorough understanding of the risk management and quality by design.
- ASQ Certified Software Quality Engineering Certification (CSQE) or equivalent.
Benefits
- Competitive salary range of $99,000.00 - $163,300.00 USD Annual.
- Opportunities for professional development and growth.
- A culture that values collaboration and innovation.
- Comprehensive benefits package.
