Job Description

Working Location: ONTARIO, RICHMOND HILLWorkplace Flexibility: OnsiteFor more than 100 years, Olympus has focused on making peoples lives healthier, safer and more fulfilling.Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.Our five Core Values empower us to achieve Our Purpose:Patient Focus, Integrity, Innovation, Impact and Empathy..**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.The Quality Assurance Engineer I is responsible for providing Quality Engineering input to support Production, Operations and Engineering activities. The Quality Assurance Engineer also:

• Maintains and follows Quality Engineering methodologies, systems, and practices which meet Olympus, customer, and regulatory requirements.
• Serves as a Quality representative to improve awareness, visibility, and communication on Quality initiatives to support departmental, functional, site, divisional and corporate Quality goals and priorities.
• When needed, works with Olympus Tokyo representatives/liaisons to resolve Quality related issues.

Job Duties

• Provide Quality Engineering support on projects to implement new product introduction or alternate repair activities.
• Maintain and support calibration and metrology programs.
• Train Technicians, Supervisors and other employees on the use of new products or processes. xc2xb7
• Perform packaging and equipment validations and other verifications/validations to support new product or new repair introductions.
• Provide technical guidance to the Change Control Board; educate members on technical issues associated with assigned projects.
• Support continuous improvement measures by providing technical information and reviewing processes as they are revised.
• Address or initiate Engineering Change Orders (COs) in a timely manner to maintain project schedules and/or achieve acceptable levels of compliance.
• Supports problem solving activities to resolve Quality issues.
• Support and/or drive corrections and corrective actions to resolve non-conformances (DMNs, NCRs, CAPAs and ADT) with minimal guidance.
• Communicate significant issues or developments identified during Quality assurance activities and support process improvements identified by cross-functional teams (CFTs) and management. xc2xb7
• Analyze Production and Complaint data and identify any significant trends. xc2xb7
• Support the Quality Management System (QMS) by performing periodic product, process, and internal audits.
• Support and participate in external audits as needed.
• Work with Operations to resolve material issues.
• Work directly with the OEM to resolve Quality problems identified through complaint investigations and/or other sources of Quality data.
• Perform all other related duties as assigned.

Job QualificationsRequired:

• Bachelors Degree in Engineering or Scientific Discipline (or equivalent) required.
• Must have strong written and verbal communication skills.
• Must be able to communicate clearly and present information concepts and ideas across all levels of the organization.
• Must have strong interpersonal skills and be able to work effectively cross-functionally.
• Ability to work with mathematical concepts such as probability and statistics.
• Ability to organize prioritize and schedule work assignments with some supervision.
• Ability to solve practical problems.
• Ability to work on multiple project tasks and assignments efficiently.
• Basic understanding of 5S and other forms of waste elimination in the Production environment
• Working knowledge of ISO 13485 and FDA Regulations.
• Domestic travel 10%.
• Occasional teleconference with global Olympus Corporation partners.

Preferred:

• Minimum of 1-2 years operating in any Engineering position, preferably Quality Engineering in a highly regulated manufacturing environment (medical devices, biotech, pharmaceuticals, etc.) is optimal.
• Basic understanding of good manufacturing practices (GMP) preferred
• Proficient in Microsoft Office. Working knowledge of Datasweep, Salesforce and SAP preferred.

Why join Olympus?We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.Equitable Offerings you can count on:Competitive salaries, annual bonusComprehensive medical benefits and pension planGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption AssistanceConnected Culture you can embrace:Work-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsDiversity Equity & Inclusion Initiatives including Employee Resource GroupsDedicated Training Resources and Learning & Development ProgramsPaid Educational AssistanceAre you ready to be a part of our team?.At Olympus, we are committed to Our Purpose of making peoples lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.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 .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.Lets 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.Applicants with Disabilities:As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).Posting Notes: || Canada (CA) || Ontario (CA-ON) || Richmond Hill || Quality & Regulatory Affairs (QA/RA)

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