Quality Manager at Olympus Corporation of the Americas in Center Valley, PA
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 Quality Manager is responsible for managing the activities in support of the current and future Quality Management System at Olympus OAI. The Quality Manager champions, develops and promotes quality activities to meet regulatory and quality requirements while supporting business goals and improving customer satisfaction. The Quality Manager is accountable for developing and executing solutions relating to quality and ensuring the Quality Management System is implemented and maintained effectively in the organization. The Quality Manager is the Management Representative for the assigned location and works cross-functionally to ensure quality processes and principles are implemented across the organization. Job Duties Serves as the Management Representative for the location. 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. Ensures Management Review is conducted per policy. 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. Ensure the Quality Management System is effectively being maintained in the organization. Develop and revise Policies, SOP and WI as needed. Manage and oversee processes relating to product quality throughout product lifecycle. Manage and champion quality systems and tools, such as CAPA, Non- Conformance Reporting, Audit etc. and related activities. Manage change control process and document control activities. Manage activities related to product acceptance. Identify and coordinate training programs on the Company's quality system(s) across all departments. Develop and execute strategies for addressing quality issues. Communicates issues or developments identified during quality assurance activities and provides recommended improvements. Assists in the evaluation and qualification of suppliers, manufacturers and vendors. Oversee the maintenance and control of quality documents, business documents, labelling and training material. Monitor key performance indicators and prepare progress reports for Quality Review meetings and for senior management. Perform special assignments as directed Job Requirements REQUIRED QUALIFICATIONS Bachelor's degree in engineering or technical discipline. 5
years of experience of improvement and/or maintaining quality management system within Medical Device or regulated industry. Demonstrated knowledge of Quality (Audit, Change Control, NC, CAPA, Deviations, etc) is required. Availability to take evening and early morning teleconferences. Experience with quality system development, implementation and maintenance. Ability to manage multiple projects, prioritize and meet competing deadlines. PREFERRED QUALIFICATIONS Demonstrated knowledge of FDA Quality System Regulations and ISO13485 preferred. Strong analytical, organizational and oral/written communication skills required. Self-motivated and able to work independently in a multi-task environment. Working knowledge of MS Office applications and ERP systems.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
years of experience of improvement and/or maintaining quality management system within Medical Device or regulated industry. Demonstrated knowledge of Quality (Audit, Change Control, NC, CAPA, Deviations, etc) is required. Availability to take evening and early morning teleconferences. Experience with quality system development, implementation and maintenance. Ability to manage multiple projects, prioritize and meet competing deadlines. PREFERRED QUALIFICATIONS Demonstrated knowledge of FDA Quality System Regulations and ISO13485 preferred. Strong analytical, organizational and oral/written communication skills required. Self-motivated and able to work independently in a multi-task environment. Working knowledge of MS Office applications and ERP systems.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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