Fellow Quality System Engineer

About the role

Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provide quality engineering support within technical development concepts, new product development, operational, or system/services support. Collaborate with Quality management to recommend, design and implement functional process improvements. Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Your Responsibilities

• Applies experienced technical quality engineering principles to assigned products or sites and guides them into implementation.
• Champion departmental or cross-functional engineering initiatives.
• Provide project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
• Identify and implement effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
• Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
• Advise management on potential improvements or enhancements to quality systems and processes in the company.

Quality System Requirements

Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Minimal Qualifications

• Bachelor’s degree in Engineering, Science, Quality, Regulatory, or a related technical discipline.
• Minimum of 10 years of quality systems, quality engineering, manufacturing quality, or regulated industry experience, preferably within the medical device industry.
• In-depth knowledge of global quality system regulations and standards, including FDA 21 CFR 820, ISO 13485, EU MDR, and other applicable regional regulatory requirements.
• Demonstrated experience leading or stewarding global quality system processes, procedures, policies, or communities of practice across a matrixed organization.
• Experience developing, maintaining, and improving quality assurance programs, process controls, procedures, metrics, and governance models that support compliance and continuous improvement.
• Proven ability to serve as a subject matter expert for quality system requirements, including interpretation of regulations and implementation of new or revised requirements.
• Experience supporting internal and external audits, including audit preparation, audit-facing subject matter expertise, response strategy, and corrective action support.
• Proven ability to lead complex quality projects of significant scope, including cross-functional initiatives, strategic roadmaps, process improvements, and compliance-related projects.
• Strong written and verbal communication skills, including the ability to clearly communicate technical, regulatory, and quality system information to leadership and cross-functional stakeholders.
• Ability to work effectively across Quality, Manufacturing, Engineering, Regulatory, Supply Chain, and site/divisional teams in a highly matrixed, global environment.

Preferred Qualifications

• Advanced degree in Engineering, Science, Quality, Regulatory, Business, or a related field.
• Extensive experience in a medical device, life sciences, or similarly regulated manufacturing environment.
• Direct experience with one or more quality system processes such as CAPA, nonconforming materials, production and process controls, process acceptance activities, design controls, supplier quality, audits, document control, or management review.