- Our company is a leading global provider of in vitro diagnostics.
- We have an established track record for providing high-quality products and services to the global clinical laboratory and immunohematology communities.
- We are recruiting and retaining the best and brightest around the world.
- People who are performance driven, want to make a difference and who help us grow our leadership position in a changing marketplace.
- The power to reimagine starts with empowered people. People who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.
- Our purpose is simple: to improve and save lives with diagnostics. We do that by re-imagining what’s possible.
The Career Potential:
- Our company is committed to improving and saving lives with diagnostics.
- To do this we hire people who share this dream and are ready for new adventures.
- As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before.
- There is no limit to the experiences, opportunities and new directions you will have access to here at our company
- More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
- The Quality Engineer ( QE) takes direction from the manager to provide oversight of quality management in international distribution channels by executing uniform quality assurance activities and promoting a quality culture to ensure product conformity.
- The QE ensures the management of non-conformance, CAPA, quality metrics, control of processes for assigned product lines.
- The QE participates in third party and external audit assessments, Lead second party (supplier) audits.
- The QE develops effective working relationships with stakeholders and suppliers, consistent with a quality oversight model .
- The QE Identifies opportunities to continuously improve quality, cost, and time factors, consistent with business objectives, manage the changes (process) to ensure control of products
- The work shall be performed to ensure compliance with Regulatory requirements (cGMP, cGDP, ISO9001, ISO13485, 21 CFR 820
Flawless execution :
- Provide Distribution Quality control (e.g Stop Ship, Inbound, rework activities, PAL management, Cold Chain management, Item creation, open maket , Non Conformance Disposition for assigned product lines and in back up situation in accordance with the company/department procedures and compliance with WW Quality System regulations.
- Gatekeeper for product quality from receipt to distribution
Quality System :
- Manage Distribution Quality deviation. In Incident management, is expected to work with peers, stakeholders, managers and provide leadership for implementation of correction/ CAPA and effectiveness assessment
- Generate metrics and provide update reports on the management system effectiveness to line manager.
- Provide leadership related to third party and other external audits.
- Supplier Audits: lead audits and surveillance visits on supplier / distributors
- Lead change control activities relative to department procedure and process. Work in collaboration with stakeholders, managers to effectively deliver change management.
- Supplier/ Distribution performance and monitoring
- Manage supplier/ distribution related activities, including non-conformances, Scorecards, Quality Agreements, input for business reviews
- Management and coordination of the project quality activities in line with project requirements, WW Quality System regulations and cGDP.
- Minimum of bachelor degree in Chemistry, Biochemistry, Biology and/or in quality is required
- Preferred: master degree in Chemistry, Biochemistry, Biology and/or in quality
- 3 to 5 years’ experience within a medical device environment, preferred In vitro diagnostics environment.
- IRCA Lead auditor qualification or equivalent
- Fluent English mandatory Effective interpersonal, verbal and written communication skills.
- Ability to think out of the box, promotes the possibility of innovation and learning.
- Ability to prioritize tasks to meet deadlines. Demonstrates a sense of actions on priorities.
- Ability to develop a wide range of solutions for issues managements.
- Demonstrated analytical skills to proactively identify and solve problems.
- Ability to understand business implications related to projects/opportunities.
- Customer oriented.
- Willingness to cooperate as part of a team, actively seeks for feedback, gives and receives candid feedback, gain trust of others.
- We are proud of the empowering, inclusive and innovative culture we are growing.
- Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making our company a place to grow your career.
- Our company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.