Director of Quality

Working Location: MINNESOTA, BROOKLYN PARKWorkplace Flexibility: OnsiteAre you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.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 ViewWe deliver on our purpose and our core values by staying True to Life.Job DescriptionProvides 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.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.

Job QualificationsRequired:

Bachelor's degree or equivalent; and ten plus years related experience. and preferably in medical device industry.

Requires background and familiarity with U.S. FDA QSR requirements including MDD 93 42 ISO 13485 2003 and Canadian Medical Device requirements.

Travel up to 10% of the time.

All other essential related duties as required

Preferred:

Japanese Pharmaceutical Affairs Law (JPAL) certification preferred.

ASQ certifications in one or more of the following areas is preferred but not required: ASQ Certified Manager of Quality Organizational Excellence (CMQ QE), Certified Quality Auditor (CQA), or Certified Quality Engineer (COE).

Working knowledge of problem solving skills good statistical and analytical skills.

Proven success in driving cultural change.

Proven Management and leadership skills; ability to lead and manage cross functional teams.

Proficient in the use of Information Technology.

Why join Olympus?Here, people matter—our health, our happiness, and our lives.

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

Comprehensive Medical, Dental, Visions coverage effective on start date

24/7 Employee Assistance Program

Free virtual live and on-demand wellness classes

Work-life balance supportive culture with hybrid and remote roles

12 Paid Holidays

Educational Assistance

Parental Leave and Adoption Assistance

Volunteering and charitable donation match programs

Diversity & Inclusion Programs including Colleague Affinity Networks

On-Site Child Daycare, Café, Fitness Center

US OnlyLimited locationsWe care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .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 .Olympus is dedicated to building a diverse, inclusive and authentic workplaceWe recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.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.Posting Notes: United States (US) Minnesota (US-MN) Brooklyn Park Quality & Regulatory Affairs (QA/RA)