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Quality Engineer

Company: ZEISS Meditec Production
Location: Ontario
Posted on: May 16, 2020

Job Description:

QUALITY ENGINEER

ONTARIO, CA

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 production equipment.
* 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 method validation.
* Generate or apply statistical methods with appropriate risk-based justification.
* Support NCR and CAPA investigations, improvements and effectiveness verification testing.
* Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
* 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 maintain compliance.
* 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 standards.
* Maintain expertise in both current and emerging requirements and quality trends as they relate to medical device products worldwide.
* Facilitate group meetings and project leadership that drives to comprehensive technical solutions for multiple issues and projects simultaneously.
* 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 required.

QUALIFICATIONS:

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 functions.
* BS Engineering - Mechanical, Industrial/Manufacturing, Biomedical engineering or science technical discipline
* 3+ years experience in engineering, science, technical and/or quality.
* Strong understanding of medical device manufacturing processes and products
* Experience with general quality principles, procedures and methodologies
* Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
* 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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