Quality Systems Spec

hace 2 semanas

Tijuana, México Medtronic A tiempo completo

**Careers that Change Lives
**A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- Co-ordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

**Must Have: Minimum Requirements
- Bachelors degree required
- Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

**Nice to Have**
- Bachelor's degree in Engineering Industrial or similar
- Experience minimun of 2 years relevant
- Advanced Statistical Technique
- Excellent English written and oral communication skills.
- Strong interpersonal skills.
- Knowledge of the industry regulations and ISO standards.

**Preferred Requirements**:

- Data analysis experience
- Quality System knowledge
- Two years experience within Supplier Quality
- Four years experience within the medical device/pharmaceutical industry.
- Experience with quality tools and process improvement techniques.
- Experience with Agile database management or other IT-related skills

**Essential Functions**:

- Serve as a vital resource for Supplier Quality Assurance team maintaining a Global Approved Supplier List (ASL). This includes adding suppliers to the ASL per Medtronic’s 019 Purchasing Controls and maintaining these suppliers to ensure compliance. Additional responsibilities are shown below.
- Subject matter expert on Purchasing Controls, ASL & supplier file requirements; advises sites outside of normal responsibilities.
- Qualifies suppliers according to company standards.
- Resolves supplier-related problems as they occur.
- Provides technical guidance and quality compliance for Supplier Quality peers.
- Collaborates with site representatives to add new suppliers for new products.
- Has a large Medtronic wide network to get people in touch with the right people quickly.
- Monitors supplier files to identify risks
- Supports site during internal and external audits including front room MAP support.
- Supports multiple sites adding new suppliers in Agile and creating the file structure architecture.
- Owns TrackWise Task PRs to address supplier file non-compliance.
- Coach peers through the 019 process when needed.
- Support site specific projects when needed.
- Participate in Supplier Quality activities and special projects.

**About Medtronic
**Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

  • Quality Systems Spec

    hace 2 días

    Tijuana, Baja California, México Medtronic A tiempo completo

    **Careers that Change Lives**A Day in the LifeResponsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and...

  • Quality Systems Manager

    hace 1 semana

    Tijuana, México Emprego MX A tiempo completo

    Descripción y detalle de las actividades - The Manager Quality Systems is responsible for assisting the Quality Systems Director in the organization, administration of, and adherence to the company Quality Management System. - Manage exempt and non-exempt Quality Systems staff and assure that quality system activities are compliant and are adding value. -...

  • Quality Systems Engineer I

    hace 1 mes

    Tijuana, México Haemonetics Corp. A tiempo completo

    We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details - Completes special testing and investigative reports as assigned by the Quality Engineering manager. - Assists in...

  • Quality Systems Engineer I

    hace 2 días

    Tijuana, Baja California, México Haemonetics Corp. A tiempo completo

    We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.Job Details Completes special testing and investigative reports as assigned by the Quality Engineering manager. Assists in manufacturing...

  • Quality Systems Qms

    hace 2 días

    Tijuana, Baja California, México North American Production Sharing A tiempo completo

    QUALITY ENGINEER - QMS & Lab ComplianceResponsibilities & Key Knowledge: Planning and executing comprehensive audits of processes, products, and systems to ensure compliance with quality standards and requirements. Audits engineering development labs, present findings to engineering, provide compliance training and maintain employee training records....

  • Quality Systems Engineer

    hace 2 meses

    Tijuana, México Emprego MX A tiempo completo

    **Descripción y detalle de las actividades** - Key responsibilities: -Define and oversee effective implementation of the Quality Management System.Define and maintain the Quality Manuals and Procedures and ensure contents are appropriate for the company.Perform gap analysis to detect opportunities areas to improve internal and external quality/manufacturing...

  • Spec, Quality

    hace 6 días

    Tijuana, México Baxter Healthcare - Welch Allyn de Mexico, S. de R.L. de C.V. A tiempo completo

    Descripción y detalle de las actividades - Leads or participates in NCR, SNCR, CAPA activities in accordance with established procedures and ensures compliance with quality objectives. *Leads/oversees validation activities, IQs, TMVs, OQs, PQs, for designated areas. *Assists management and departmental staff in the implementation of statistical quality...

  • Quality Systems Engineer

    hace 7 días

    Tijuana, México Emprego MX A tiempo completo

    Descripción y detalle de las actividades Key responsibilities: -Define and oversee effective implementation of the Quality Management System. -Define and maintain the Quality Manuals and Procedures and ensure contents are appropriate for the company. -Perform gap analysis to detect opportunities areas to improve internal and external quality/manufacturing...

  • Spec, Quality

    hace 2 días

    Tijuana, México BAXTER A tiempo completo

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Spec, Quality

    hace 1 día

    Tijuana, Baja California, México BAXTER A tiempo completo

    This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...

  • Spec, Quality

    hace 2 meses

    Tijuana, México Baxter A tiempo completo

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Spec, Quality

    hace 2 semanas

    Tijuana, México Baxter A tiempo completo

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • R7386 Quality Systems Engineer I

    hace 2 semanas

    Tijuana, México Emprego MX A tiempo completo

    Descripción y detalle de las actividades Experiência y requisitos Completes special testing and investigative reports as assigned by the Quality Engineering manager. Assists in manufacturing quality systems, product quality and customer quality requirements. Develops, reviews and challenges existing quality driven test systems and procedures to assure...

  • Quality Systems Qms

    hace 2 meses

    Tijuana, México North American Production Sharing A tiempo completo

    **Q**UALITY ENGINEER - **QMS & **Lab Compliance** **R**esponsibilities **& Key Knowledge**: - Planning and executing comprehensive audits of processes, products, and systems to ensure compliance with quality standards and requirements. - Audits engineering development labs, present findings to engineering, provide compliance training and maintain employee...

  • Sr Quality Systems Engineer

    hace 5 días

    Tijuana, México Haemonetics Corp. A tiempo completo

    We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details JOB SUMMARY: Responsible for developing and coordinating implementation of quality systems, procedures, test methods,...

  • Quality Systems Engineer

    hace 1 semana

    Tijuana, México Springs Window Fashions de Tijuana, S. de R.L. de C.V. A tiempo completo

    Descripción y detalle de las actividades JOB PURPOSE: - The Quality System (QMS) Engineer has responsibility to coordinate the deployment and sustaining of the QMS in SWF Tijuana. Aid in developing, implement, and maintain quality assurance and control systems for SWF Tijuana - Administrates the document control system and ensures the proper release,...

  • Quality Systems Engineer

    hace 2 días

    Tijuana, Baja California, México Springs Window Fashions De Tijuana, S. De R.L. De C.V. A tiempo completo

    y detalle de las actividadesJOB PURPOSE: The Quality System (QMS) Engineer has responsibility to coordinate the deployment and sustaining of the QMS in SWF Tijuana. Aid in developing, implement, and maintain quality assurance and control systems for SWF Tijuana Administrates the document control system and ensures the proper release, distribution and record...

  • Sr Quality Systems Engineer

    hace 2 meses

    Tijuana, México Haemonetics A tiempo completo

    We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details JOB SUMMARY: Responsible for developing and coordinating implementation of quality systems, procedures, test...

  • Sr Quality Systems Engineer

    hace 2 semanas

    Tijuana, México Haemonetics A tiempo completo

    We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details JOB SUMMARY: Responsible for developing and coordinating implementation of quality systems, procedures, test...

  • Sr Quality Systems Engineer

    hace 2 días

    Tijuana, Baja California, México Haemonetics A tiempo completo

    We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details JOB SUMMARY: Responsible for developing and coordinating implementation of quality systems, procedures, test...