Site Quality Systems Director
Job description
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 Director, Site Quality System provides leadership at the Center Valley, Breinigsville, and Westborough locations ensuring that the QMS 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 supporting, procurement, manufacturing, returns and servicing of products managed at the locations. Is the Management Representative for both the locations.
Job Duties
- Serves as the Management Representative for Westborough, Breinigsville and Center Valley locations.
Manages facility audits by outside agencies and internal Olympus compliance group to demonstrate compliance to regulatory requirements and Quality System.
Ensures audits conducted that result in deficiencies are corrected per policy.
Manages the development and performance of staff. Ability to assess and develop team talent to support business objects and personal objects of employees.
Prioritize resources based on the strategic objectives of the organization.
Establishes the departments objectives (MBO) to meet Quality Objectives organizations goals and strategic plan.
Provides leadership in establishing processes or systems to support the Quality Systems vision for the locations .
Drives the development and deployment of innovative global policies requirements and strategies for Quality Systems.
Change agent to break down barriers to prepare and influence direct team other functions at locations to new ideas and ways to execute Quality Systems sub-systems to improve Olympus compliance profile.
Leads quality sub-system process improvement projects to increase efficiency of the QMS at the locations.
Leads QMS governance through execution of Management Review, CAPA, Non-Conformance, and audit sub-system ownership for locations.
Accountable for QMS KPI execution results. Monitor key performance indicators and prepare progress reports for Quality Review meetings and for senior management.
Develops QMS competency for all employees at the locations.
Champion the development, implementation and continuous improvement of a Quality Management System to meet applicable standards and regulations and/or harmonize with global Olympus Quality Systems. Develop and revise Policies, SOP and WI as needed.
Manage activities related to product acceptance and Ship Hold Communicates issues or developments identified during quality assurance activities and provides recommended improvements. Develop and execute strategies for addressing quality issues.
Perform special assignments as directed
Job Requirements
REQUIRED QUALIFICATIONS:
Bachelor’s degree in engineering, technical discipline, or equivalent.
Minimum of 7 years of experience supporting or working within a medical device, or any other regulatory controlled industry.
Minimum of 7 years of experience of improvement and/or maintaining quality management system within Medical Device or regulated industry.
Minimum of 5 years’ experience in a leadership role managing people ideally across multiple locations.
Experience with U.S. FDA QSR requirements, ISO13485, ISO14971, Japanese Pharmaceutical Affairs Law (JPAL), and Canadian Medical Device requirements.
Travel: Domestic 25%, between Westborough, MA and Center Valley, PA.
Flexible working hours across multiple time zones for product related issue.
PREFERRED QUALIFICATIONS:
Highly motivated strategic thinker with strong leadership, organizational, proven problem-solving and decision-making capabilities.
Proven success in driving and managing cultural change
Ability to understand business needs/requirements and system capabilities to develop efficient and effective solutions.
Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.
Highly proficient in Microsoft Word, PowerPoint, Excel, Visio, Project
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.
Olympus…True 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) || Pennsylvania (US-PA) || Center Valley ||
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