Company: ZEISS Meditec Production
Posted on: May 16, 2020
Step out of your comfort zone, excel and redefine the limits of
what is possible. That s just what our employees are doing every
single day in order to set the pace through our innovations and
enable outstanding achievements. After all, behind every successful
company are many great fascinating people.
WE ARE LOOKING FOR PEOPLE WHO ARE KEEN TO TRY SOMETHING NEW:
* Collaborates with engineering and manufacturing functions to
ensure quality standards are in place.
* Devises and implements methods and procedures for inspecting,
testing and evaluating the precision and accuracy of products and
* Use knowledge of statistics on acceptance criteria, DOE and
comparison testing to support development engineers in the
development of compliant test plans and reports to meet regulatory
requirements and quality objectives.
* Support manufacturing continuous improvement and development as
the Quality team member for validation including IQ, OQPQ and test
* Generate or apply statistical methods with appropriate risk-based
* Support NCR and CAPA investigations, improvements and
effectiveness verification testing.
* Ensures that corrective measures meet acceptable reliability
standards and that documentation is compliant with
* Support risk assessment processes for manufacturing and
development including FMEA, ensuring risk assessments are thorough
and documentation meets all governing requirements.
* Define critical to quality characteristics and inspection plans
for components, subassemblies, and finished devices.
* Identify and propose remediation for existing and potential
quality issues; act as project team quality solution provider to
* Ensure that product development projects and changes to existing
products are conducted in compliance with the FDA Quality System
Regulation, ISO 13485 Regulations, and other applicable
* Maintain expertise in both current and emerging requirements and
quality trends as they relate to medical device products
* Facilitate group meetings and project leadership that drives to
comprehensive technical solutions for multiple issues and projects
* Ensure internal quality processes, procedures and systems are
compliant to all governing standards.
* Participate and assist as a part of the Internal Audit team as
To perform this job successfully, an individual must be able to
perform each essential duty satisfactorily. The requirements listed
below are representative of the knowledge, skill, and/or ability
required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential
* BS Engineering - Mechanical, Industrial/Manufacturing, Biomedical
engineering or science technical discipline
* 3+ years experience in engineering, science, technical and/or
* Strong understanding of medical device manufacturing processes
* Experience with general quality principles, procedures and
* Strong understanding of regulatory requirements (i.e.: ISO,
* Strong statistical analysis techniques
* Strong technical writing skills
* Execution of NCR and CAPA Processes
* Process Validations - IQ/OQ/PQ's In a spacious modern setting
full of opportunities for further development, ZEISS employees work
in a place where expert knowledge and team spirit reign supreme.
All of this is supported by a special ownership structure and the
long-term goal of the Carl Zeiss Foundation: to bring science and
society into the future together.
JOIN US TODAY. INSPIRE PEOPLE TOMORROW.
Diversity is a part of ZEISS. We look forward to receiving your
application regardless of gender, nationality, ethnic and social
origin, religion, philosophy of life, disability, age, sexual
orientation or identity.
Apply now! It takes less than 10 minutes.
We are an EEO/AA/Veterans/Disabled employer.
Keywords: ZEISS Meditec Production, Ontario , Quality Engineer, Engineering , Ontario, California
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