Job Description

About Us:
How many companies can say they've been in business for over 179 years?!
Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles ever-changing environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!
Location/Region: This position is located in Halifax, Nova Scotia.
What's the role?
Join Zeiss Meditec-Halifax as a Quality Manager Engineering and become an integral part of our pioneering ETP R&D hub in Halifax, Nova Scotia. We are looking for a passionate, collaborative, and adaptable professional who thrives in a dynamic, cross-functional environment. If you have a solutions-oriented mindset and are dedicated to advancing medical technology through exceptional product quality and compliance, this role is an ideal fit for you.
As a Quality Manager Engineering, you will play a key role in supporting the development of cutting-edge medical products while closely monitoring the development process. You will lead comprehensive risk analyses to ensure product reliability and provide expert guidance to process owners on optimizing effectiveness and efficiency. Additionally, you will oversee the preparation and execution of external audits and fulfill responsibilities as an internal auditor and local process owner.
Sound Interesting?
Here's what you'll do:

• Cross-Functional Collaboration: Work seamlessly with a diverse team, including R&D, manufacturing, purchasing, and marketing, to achieve project goals.
• Support and Monitor Development: Oversee the development process for projects focused on innovative medical devices, ensuring timely and effective execution.
• Product Quality and Documentation: Uphold the highest standards of product quality and compliance with good documentation practices, ensuring completeness and accuracy in all product and project documentation.
• Risk Management: Lead the risk management team in identifying and assessing hazards, and developing robust countermeasures to protect patients, users, and third parties. Maintain a comprehensive risk file throughout the product life cycle.
• Design FMEA: Facilitate the Design Failure Mode and Effects Analysis (dFMEA), ensuring the effective implementation mitigations.
• Root-Cause Analysis: Direct root-cause analyses in response to customer complaints, implementing corrective and preventive measures to enhance product quality.
• Process Advisory: Advise project managers and teams on effective and efficient application of processes, supporting continuous improvement initiatives.
• Audit Preparation and Implementation: Act as the Quality Management Representative to regulatory authorities and notified bodies, leading the preparation and execution of internal and external audits, as well as supplier audits.
• QMS Management: Manage the legacy electronic Quality Management System (eQMS), including creating and revising process documents, supporting process owners, and facilitating training. Lead the transition to the ZEISS QMS.

Do you qualify?

• Educational Background: Degree in engineering (master's degree preferred).
• Professional Experience: Minimum of five years in development projects, ideally within a highly regulated environment such as medical technology.
• Analytical Skills: Strong analytical, structured, and solution-oriented approach to problem-solving.
• Interpersonal Skills and Communication: Enthusiasm for working collaboratively within interdisciplinary teams, fostering a cooperative and productive work environment.
• Risk Management Expertise: Experience in risk management in accordance with ISO 14971 or comparable standards.
• Reliability Management Knowledge: Understanding of reliability management principles and practices.
• Defect Analysis and Technical Statistics: Proficiency in defect analysis and technical statistics within quality management frameworks.
• Medical Standards Knowledge: Familiarity with medical standards and international medical device regulations.
• Technical Knowledge: Broad knowledge of optics, mechanics, electronics, and software. Proficiency with eQMS and relevant software tools. Experience with any of the following is considered an asset: Confluence, Jira, Minitab, Polarion, SAP, APIS IQ.
• Language Skills: Proficiency in English, with basic German language skills considered an asset.

WORKING ENVIRONMENT:

• Onsite Collaboration: As part of our lean R&D team, onsite work in our Halifax office during regular hours is essential for collaborative success.
• Travel Opportunities: Occasional travel may be required to other ZEISS locations, including Oberkochen, Germany and California, USA.

ZEISS is an Equal Opportunity Employer
Your ZEISS Recruiting Team: Jo Anne Mittelman
Accommodation
ZEISS is committed to creating an accessible and inclusive organization. We are committed to providing barrier-free and accessible employment practices. Should you require Code-protected accommodation through any stage of the recruitment process, please make them known when contacted and we will work with you to meet your needs.

Skills Required