Design Quality Associate Director

Design Quality Associate Director

The Design Quality Associate Director will ensure that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system. The Design Quality (DQ) Associate Director will work with the existing DA teams to: Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product. DQ Associate Director will ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Exceed customer expectations by responding to field events in a professional and timely manner. Minimize the number of field events by building in quality into the design, through effective analysis of returned products, corrective actions and timely investigation and response to field events and post market monitoring through post market surveillance activities.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week.

Visa sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Relocation assistance is available for this position.

Your responsibilities will include:

• Oversee the continued organization and development of Therasphere Design Assurance team, providing Design Quality expertise and support for technical advancement, regulatory compliance, and operational systems and services throughout ongoing projects.
• Lead the growth and direction of the Design Assurance team dedicated to Therasphere.
• Work collaboratively with manufacturing partners, with a focus on the advancement of Therasphere operations within China.
• Work collaboratively with R&D, Regulatory, PMO, Clinical and Operations
• Support the ongoing Sustaining of the TheraSphere product.
• Support the preparation and staffing and audit excellence for TheraSphere products
• Recruits, coaches and develops organizational talent.
• Manages both NPD, Sustaining and VIP activities with existing DA teams
• Responsible for the communication and documentation of internal information related to design quality assurance and compliance, as appropriate
• Applies effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving divisional design quality issues
• Leads the execution of streamlined quality systems and methodologies, which effectively identify and resolve design quality issues
• Keeps abreast of and act as an expert (within division) for current applicable worldwide regulatory & design quality assurance and compliance requirements
• Leads and supports departmental, functional and divisional design quality goals and priorities
• Acts as leader (divisional) in supporting design quality disciplines, decisions, and practices
• Builds quality into all aspects of work by maintaining compliance to all quality requirements
• Leads and participates in various design quality assurance and compliance improvement projects as a (divisional) subject matter expert
• Other duties as necessary or required by the department, division, or organization

What we're looking for in you:

Required Qualifications:

• Minimum of a Bachelor's degree
• Minimum of 5 years of Design Quality (AKA Design Assurance) engineering experience in a medical device or regulated environment or similar related work experience
• Minimum of 5 years of direct or indirect management experience
• Demonstrated ability to lead effectively across a broad set of cross functional partners/teams and diverse body of work/functions/sites in a highly matrixed environment
• 10% - 20% travel expectations

Preferred Qualifications:

• Advanced degree preferred
• Familiarity with BSC products and customer needs
• Minimum 10 years experience in Medical devices
• Experience with Pharma
• Experience with product that include Software or embedded firmware
• Complex problem solving
• Demonstrated ability to influence and drive consensus across multiple parties in a highly matrixed organization
• Ability to be innovative and drive new perspectives based on industry standards and best practices
• High sense of urgency and commitment to execution
• Proven adaptability, comfortable with change and demonstrated ability to react and respond to a fast changing environment.