Director of Quality

at  Olympus Corporation of the Americas

Workplace Flexibility: Onsite
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

JOB DESCRIPTION

Provides strategic leadership at the OSTA site in the and directs the execution of the Quality System to ensure compliance is maintained with regulatory requirements along with the business strategy of the company. Serves as the Quality Leader providing training and mentoring to the organization in quality matters supports new product development procurement manufacturing returns and servicing of products produced at the location. Is the Management Representative for location. Provides guidance and expertise across OSTA in various quality initiatives and serves as a delegate for the Executive Director of OPS Quality. Leads OSTA wide quality projects and initiatives.

ABOUT US:

Our 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 costs, and enhance the quality of life for patients and their safety.
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.

OUR PURPOSE IS TO MAKE PEOPLE’S LIVES HEALTHIER, SAFER, AND MORE FULFILLING.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View
We deliver on our purpose and our core values by staying True to Life.

JOB DUTIES

• Manages Quality staff to support new product development procurement manufacturing and servicing processes.
• Ensures location personnel are trained to meet their respective responsibilities and duties. Mentors and leads Quality Engineers.
• Recognizes the development needs of individuals within the department and acts on those needs.
• Serves as a subject matter expert in Quality Engineering for OSTA.
• Mentors Quality organization across OSTA in developing quality skills.
• Responsible to ensure requirements of the Quality System are applied and adhered to for the location products and services produced.
• Supports validation and verification strategy for new and existing products and processes.
• Ensures that the quality procedures are accurate reflecting the quality system and ensures that they are implemented correctly.CAPA board member and is responsible to ensure an effective process.
• Ensures that corrective actions are adequately researched validated and implemented.
• Manages the product complaint system to ensure timely customer response and corrections.
• Utilizes and promotes the use of data in the analysis of business compliance and performance. Monitors performance metrics and acts upon trends (positive or negative).Ensures proper disposition of non conformances.
• Ensures the appropriate management of all QS documentation including change orders DHF DMR DHR labels and labelling etc.
• Ensures internal vendor and process audits are conducted to schedule with corrections made for any deficiencies observed.
• Develops negotiates and implements quality agreements between company entities.
• Supplier Review Board member and ensures that suppliers are qualified to supply components to meets the design requirements.
• Responsible for control of condition for sterile manufacture integrity of sterile packaging approval of goods purchased sterile sterilization contractors and sterilization cycle validation. (As applicable to the location).
• Budget responsibility for the Quality organization for the location and monitor performance to budget. Leads Quality initiatives projects that affect all OSTA sites.
• Serves as the Management Representative for the location.
• Manages facility audits by outside agencies (i.e. FDA ISO) to demonstrate compliance to regulatory requirements and Quality System. Ensures audits conducted that result in deficiencies are corrected per policy.
• Ensures semi annual Management Review is conducted per policy. Senior Management at site representing Quality.
• Stake holder and collaborator with senior management (site and corporate) relating to business and quality decisions.
• Drives business strategy within the organization for process and product continuous improvement. Drives change to ensure continuous improvement in quality processes and performance.
• Develops and drives measurable Quality improvements relating to products processes and services.
• Communicates significant issues to site senior management and corporate management and that plans for correction are developed.