Executive Director, Design Assurance - APAC

Working Location: MASSACHUSETTS, WESTBOROUGH

Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day.

Let's inspire healthier lives, together.

Job Description

The Executive Director, APAC Design Assurance will be responsible for guiding, directing and managing the quality engineering team responsible for providing quality support for Product Development (PD) and Product Life Cycle Management (PLCM), focusing on design controls, including new product development and ongoing product support. The Director will provide strategic direction and guidance for design controls and changes to existing products ensuring compliance to regulations. The position requires high level management and insight into development projects to ensure time-to-market and technology objectives are met while ensuring that the Quality Management System requirements are adhered to.

Job Duties

* Establish strategic vision and direction for the Americas Design Assurance Group.

* Provide expertise and support for development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility.

* Oversee all Quality Support for the PLCM program, leading quality initiatives and identifying/managing continuous improvement projects with the objective of achieving quality and cost improvements.

* Ensure project plans adequately address design, validation and Quality departmental requirements and standards, ensuring tasks are executed compliantly.

* Management and documentation of Design Control activities through post launch review (approximately 1 year post launch).

* Develop and implement appropriate risk management strategies and programs.

* Develop plans for integration of new products, transfers, and mergers.

* Develop quality engineering function capable of providing guidance and tools for product development and problem solving using appropriate tools (Six Sigma, SPC, DMAIC).

* Interpret industry and government regulations and be creative in application of these regulations to practically implement to optimize compliance and business processes.

* Responsible for development of metrics, management of data and presentation of data to management in accordance with Management responsibility procedure.

* Maintain current knowledge of global medical device regulations pertaining to Quality Systems, assist in facilitation of internal and third party audits as needed.

* Prepare , communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the quality system along with providing individuals with professional growth.

* Translates overall vision and values to team; establishes mid- to long-term objectives to align with company vision and accomplish organizational goals. Determines and implements best strategic direction for the function with regard to organization, competencies, human and fiscal resource planning, quality planning and Design Control best practices.

* Leads a department of less experienced professionals including performance management, goals and objective setting, and personal development planning. Assures short term training needs for staff are addressed, and longer term individual and organizational development needs are identified, planned, and implemented. Manages external resources, including consultants.

* Perform other job related duties as required.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor's Degree in engineering or other related degree field, or applicable experience in the field of medical device design assurance.

* Minimum of 15 years of experience in the field of design assurance, minimum of 5 years of experience leading teams of engineers.

* Knowledge of national and international regulations applicable to medical devices including; Human Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC

* Will work with global teams, availability will include working across the associated time zones. Travel up to 15% of the time.

PREFERRED QUALIFICATIONS:

* Six Sigma black belt a plus.

* Expected to understand strategic priorities developed by executive management and to respond to requests with appropriate urgency and with an organized approach.

* Ability to operate independently and highly autonomously, holding themselves accountable to proactively fulfill tasks and achieve results within assigned timelines. Provides solutions to highly complex, significant, and complex issues; develops solutions based on in-depth technical knowledge, company policies, or defined process paths.

* Ability to analyze and interpret all regulatory and quality guidelines needed • Demonstrate a strong "business partner" approach and attitude providing creative and innovative solutions that meet quality standards.

We realize work isn't just a job to you.

It's a big part of your life, but not the only part. That's why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks - so you can be ready for where life can take you.

Olympus requires all new hires to be "fully vaccinated" against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

OlympusTrue To You. True To Society. True To LIFE.

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.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||

Nearest Major Market: Worcester

Job Segment:

Six Sigma Black Belt, PLM, Quality Engineer, Six Sigma, Performance Management, Management, Engineering, Human Resources