**Primary Location **: Mexico-Baja California Norte-Mexicali
**Description**:
**JOB SUMMARY**:
Responsible for all QC operations, responsible of mainteining the QMS and assure its effectiveness and compliance according to Medline's policies as well as the regulatory requirements of ISO***** and MDSAP.
Coordinate all QC functions and roles to support operations departments, Coordinate customer complaints investigations for the site.
Conducts trend analysis towards continues improvement projects, reports scorecard for the site (DPM) and makes recommendations for improvements.
Work on CAPA to correct negative trendings.
This position works along with the management team to ensure compliance of the quality system and regulatory requirements.
This position requires a dynamic approach to work with operation departments and requieres strong knowledge in quality control in the medical device manufacturing environment.
Support the different programs of the organization as required.
**MAJOR RESPONSIBILITIES**:
- Assure compliance of all applicable QMS and regulatory requirements of the QMS (ISO*****, 21CFR820 and MDSAP).
- Participate and suggest changes to the QMS (ISO***** and MDSAP at MXC)
- Assure company quality objectives are met keeping a continuous improvement approach.
- Participate on QMS internal audit program.
- Coordinate interdepartamental teams to improve metrics and investigate failure modes for complaints and NCMRs.
- Manage and maintain the QMS documentation & procedures thru ETQ reliance software.
- Participate on the CAPA program and verify on time completion at all stages as needed.
- Maintain updated the Quality Scorecard and DPM indicators.
- Generate and analyze trend reports for site Leadership management.




- Train and development skills for all QC department functions and roles.
- Support environmental monitoring process as needed.
- Lead and support quality process iniciatives and projects.
- Responsible to provide on board training to new employees on the quality control.
- Lead multifunctional teams as designated by the Company.
- Support in the planning and execution of the Quality Week activities.
- Participate in the different programs of the organization as required.
- Coordinate and support strategies in conducting the Quality week for the site.
- Participate on the different Company programs as needed.
- Define roles and responsibilities for Quality control dept.
**Qualifications**:
Education
Manufacture/Industrial or related
Work Experience
Minimum 5 year of experience in Quality department functions
Experience on managing and coordinating large headcount groups
Knowledge of ISO ***** Standard and MDSAP
Experience as Internal auditor (ISO *****:****)
Extensive knowledge on GMP's.
English Intermediate Level 80% Written / Spoken
Knowledge / Skills / Abilities
- Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation is necessary.
- Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
- Experience problem solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations.
- Experience leading a team to accomplish cross-functional goals.
- Experience using MS Office Suite products (Word, Excel, PowerPoint, and Outlook).
- Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting)

📌 Quality Superintendent (2 Shift) (Mexicali)
🏢 Medline Industries
📍 Mexicali