Global Design Assurance Manager - Hybrid

Olympus America, Inc.; Westborough (MA); Hybrid; USD 122,000 - 171,000; Full time

Benefits offered by this job

401(k) with company match

Annual bonus

Wellbeing programs

Job summary

Olympus America, Inc. is seeking a Manager of Design Assurance to lead global governance, KPI-driven improvements, and cross-functional accountability across R&D, Regulatory, and Quality.

This role interfaces with senior leadership to prioritize actions and resolve complex product issues. You will drive Training Academy initiatives, coordinate audits, and ensure Design Assurance processes meet regulatory requirements in a fast-paced, global environment.

Qualifications

• Bachelor of Science in medical, engineering, or scientific discipline required.
• Minimum of 8 years of experience with at least 4 years as a quality engineer in drug/device manufacturing/distribution with focus on QSR and quality assurance.
• Experience developing training programs or curricula for quality topics (Lean Six Sigma, Design Controls, Risk Management, Statistical Methods).
• Experience supporting FDA/Notified Body audits and other regulatory inspections.
• Experience presenting to executive leadership and solving complex problems.
• Experience working in a global organization with multiple regions and locations.

Responsibilities

• Drive planning and implementation of global transformation initiatives to strengthen Olympus Design Assurance.
• Lead the Design Assurance Academy to develop standards and curricula for NPD and Sustaining DA.
• Collaborate with Global R&D Transformation Office to standardize training across DA and R&D.
• Establish DA communities of practice, training, and support for DA processes.
• Lead projects within Design Assurance Quality and monitor KPIs for global improvements.
• Lead Issue Escalation to identify and manage product issues globally with cross-functional teams.
• Use systematic problem-solving to identify, prioritize, and resolve quality issues.
• Communicate outputs to senior leadership and escalate issues needing prompt action.
• Assist audits by external regulators (FDA, MDSAP) and demonstrate regulatory compliance.

Skills

Leadership

Communication

Problem solving

Cross-functional collaboration

Global coordination

Strategic thinking

Regulatory readiness

Travel readiness

Education

B.S. in science/engineering/medical field

Job description

Olympus America, Inc. is seeking a Manager of Design Assurance to lead global governance, KPI-driven improvements, and cross-functional accountability across R&D, Regulatory, and Quality.

This role interfaces with senior leadership to prioritize actions and resolve complex product issues. You will drive Training Academy initiatives, coordinate audits, and ensure Design Assurance processes meet regulatory requirements in a fast-paced, global environment.