Working Location: Ontario, Richmond Hill Workplace Flexibility: HybridJob DescriptionThis is an 18-month contract assignment.The Manager, Site Quality System, provides leadership at the location ensuring QMS 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 location. Champions continuous improvement and alignment to the Global Quality Management System (QMS).
Job Duties- Serves as the Management Representative for the location.
- Establishes the departments objectives (MBO) to meet Quality Objectives organizations goals and strategic plan.
- Manages the development and performance of staff.
- Manages facility audits by outside agencies (Health Canada, Notified Bodies, FDA) and internal Olympus compliance group (including Corporate Compliance) to demonstrate compliance to regulatory requirements and Quality System.
- Ensures audits conducted that result in deficiencies are corrected per policy.
- Leads Management Review and it is conducted per policy.
- Champions 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 Ship Hold processes.
- 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.
- Accountable for QMS KPI execution results. Monitor key performance indicators and prepare progress reports for Quality Review meetings and for senior management.
- Perform special assignments as directed.
Job QualificationsRequired:- Bachelor's degree in engineering or technical discipline.
- Minimum of 5 years of experience supporting or working within a medical device, or any other regulatory controlled industry.
- Minimum of 3 years of experience of improvement and/or maintaining quality management system within Medical Deviceor regulated industry.
- Minimum of 3 years' experience in a leadership role managing.
- Experience with Canadian Medical Device requirements, U.S. FDA QSR requirements, ISO13485, ISO14971, Japanese Pharmaceutical Affairs Law (JPAL).
- Motivated strategic thinker with strong leadership, organizational, proven problem-solving and decision-making capabilities.
- Provides constructive feedback, coaching and mentoring.
- Excellent interpersonal skills and experience working with different cultures and levels of management.
- Can build rapport, influence without authority, and motivate teams without direct management authority.
- Excellent verbal and written communication skills, including public speaking and facilitation
- Proven success in driving and managing cultural change.
- Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
- Ability to work well under pressure in a fast-paced environment and meet deadlines with a high degree of accuracy.
- 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 analye, drive root cause, and solve problems.
- Highly proficient in Microsoft Word, PowerPoint, Excel, Visio, Project.
- Flexible working hours across multiple time zones for product related issues or Global QMS projects.
The anticipated starting base pay range for this full-time position working at this location is $97,957.00 to $132,241.00 per year plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
Artificial Intelligence is not being utilized in the Olympus hiring process.
