Quality Compliance Specialist

hace 2 semanas

Aguascalientes, México Flex A tiempo completo

At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose - to make great products that create value and improve people’s lives.

Job Summary

Job summary:

- To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a _Quality Compliance Specialist _located in _Aguascalientes_

Reporting to the Quality Compliance Manager Quality Compliance Specialist role involves working with regulations and standards that rule Medical Device Mnufacturing. Conducts analysis, evaluation, update and implementation of processes related to Process Validation, Risk Management, Control Plan in the different Medical Manufacturing areas. Stays aware of new versions and updated to standards and regulations related with Process Validation and related processes. Trains periodically to engineers in the current practices and procedures of Process Validation and related processes and is aware of the compliance of all the projects with regards of Process Validation and related processes.

What a typical day looks like:

- Update, develop and implement procedures related with Process Validation and related processes taking into account the national and international standards and regulations.
- Follow up of Process Validation projects documentation to assure compliance with the applicable procedures.
- Provides support to Flex colleagues and customers in topics related with Process Validation and related processes.
- Training periodically to personnel in charge of Process Validation activities and processes related.
- Follow up of Corrective / Preventive actions to improve process validation and related processes.
- Engagement in External Audit Processes (Customers', Regulatory, Government Agencies, etc.)
- Participate as auditor during Internal Audits.

The experience we’re looking to add to our team:

- Bachelor’s degree or equivalent or completed professional career.
- Excellent English communication skills.
- Good Excel, Power point, Office skills
- Desired experience of Process Validation or similar topics.
- Desired, certification as auditor ISO 13485:2016 and ISO19011:2018.
- Desired certification or knowledge of Green Belt or Black Belt topics.

What you’ll receive for the great work you provide:

- Competitive Salary.
- Life & Medical insurance.
- Christmas Bonus.
- Food Coupons.
- Saving Fund.

XS65

Job Category

Quality

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