Site Quality Systems Director

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