Manager, Design Assurance

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

Working Location:Massachusetts, Westborough; Pennsylvania, Center Valley

Workplace Flexibility:Hybrid

For more than 100 years,Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

The Manager, Design Assurance is responsible for supporting the global design assurance function. The Manager, Design Assurance shall have leadership, responsibility, and oversight for Design Assurance Governance Key Performance Indicators, ongoing monitoring, and action planning. This position will also gather, communicate, and manage escalated product issues by soliciting input from ship hold, HHA, FCA, regulatory affairs, clinical, complaint handling, and product quality teams. The position will present and communicate outputs of the Issue Escalation process to executive leadership and escalated any issues that require prompt resolution. The position will track and facilitate cross-functional teams to investigate and develop action plans to resolve the product issues. This role will interact directly with company executive officers and other senior leadership to ensure alignment, prioritization, and engagement.

Job Duties

• Drive successful planning and implementationof global transformation initiatives needed to build and strengthen Olympus Design Assurance as a best-in-class industry-leading organization
• Establish and lead the Design Assurance Academyto develop and evolve skill/competency standards and syllabus within both NPD and Sustaining DA organizations
• Partner with the Global R&D Transformation Office toimplement common technical and process enhanced training and curricula across Olympus DA and R&D Academies
• Establish DA communities of practice, training, toolsets and supportfor effective implementation and support of DA-owned processes and methods
• Responsible and accountable for leading projects and programs within the Design Assurance Quality space.
• This individual will develop, implement, and monitor strategic KPIs for Design Assurance globally and will drive improvement in these KPIs via focussed initiatives.
• Leads Issue Escalation Process to identify, prioritize, and manage product issues globally as well as facilitate their investigation.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner.
• Stakeholder and collaborator with Senior Leadership relating to project, process business and Quality strategies.
• Supports audits by outside agencies (FDA, MDSAP) and acts as a subject matter expert to demonstrate compliance and continuous improvement to regulatory requirements and the Olympus Quality System.
• Champion and subject matter expert for end-to-end customer and patient focussed Design Assurance.

Job Qualifications

Required:

• Bachelor of Science, medical, engineering, or scientific discipline required.
• Minimum of 8 years of experience with a minimum of 4 years as a quality engineer within a drug/device manufacturer/distributor with a focus on QSR compliance and quality assurance.
• Experience developing training programs and curriculum for quality and quality engineering topics or compentencies such as i.e. Lean Six Sigma, Design Controls, Risk Management, Statistical Methods
• Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
• Experience working with, presenting, and communicating with executive leadership. Experience in problem solving, root cause analysis, and CAPA preferred.
• Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.
• Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc.…).
• Proven leadership, teamwork, collaboration and influencing skills.
• Ability to work effectively and with agility in a fast paced and dynamic environment.
• Working knowledge of problem-solving skills good statistical and analytical skills.
• Strong written and verbal communication skills.
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Up to 40% domestic/international travel

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match

24/7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position in this location is$122,362.00-$171,307.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.