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Quality Engineer in Nationwide Mexico at Mammotome

Date Posted: 1/22/2019

Job Snapshot

Job Description

Job ID: TAS000128

About Us

In December 2014, Devicor® Medical Products, Inc. was acquired by Leica Biosystems, part of the Danaher family of companies. Leica Biosystems is the global leader in anatomic pathology solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. The combination of the two companies uniquely positions us to develop integrated patient-to-pathology solutions for the diagnosis of cancer.

Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. Mammotome remains committed to its heritage of advancing technology for early detection of breast cancer, providing support and education for clinicians worldwide, and offering breast care information for patients

Description

Responsibilities

1. Prepares qualification/validation protocols and reports of areas, facilities, manufacturing equipment, critical systems, inspection equipment, cleaning and manufacturing processes for compliance with good assembly practices per applicable standards. Performs qualification, installation and operation protocols and reports of production equipment. Performs requalification, installation and operation protocols and reports of production equipment.

2. Develop and validate   inspection testing methods.

3. Performs variable and attribute repetitiveness and reproducibility studies (GR&R)

4. Initiates and directs Non Conformances Reports and Corrective Actions to problems relating to product or process quality.

5. Minimize customer complaints due to product quality through effective Corrective Actions systems. Ensure compliance of project activities to appropriate regulations and standards (FDA, ISO)

6. Supervise and coordinate the calibration system

7. Supervise and coordinate the environmental monitoring program.

8. Supports activities to maintain the system’s valid status.

9. Participates in multifunctional continuous improvement project teams.

10. Participates in the implementation of new products and processes according to customer expectations.

11. Develops, updates and maintains standard operation procedures (SOP) for the Quality engineering function.

General Skills/Competencies/Specialized Knowledge

1. Executes quality engineering activities and functions for Devicor Medical Products de México. Participates in planning and implementation activities for new product introductions and transferences.

2. A key member of the Quality team. Implements and follows up on quality system procedures according to international norms (ISO13485, 21 CFR 820) and company policies.

3.  Responsible for Compliance programs as it relates to new and existing products.

4. Could be have employees on his charge.


Travel
USA Visa and passport required 

Work Environment And Physical Demands

Typical office environment

Job Requirements



Qualifications

Experience

 Minimum up to 5 year experience at engineering level.

 Knowledge of MS Office, Minitab and Outlook.

 Experience with statistical tools (SPC, DOE, ANOVA).

 Experience with FMEA, Control Plans, GR&R’s.

 Experience with process validation and inspection methods.

 Experience with root-cause analysis, corrective actions and customer complaints.

 Experience in managing multiple projects.

 Certifications: ASQ, Six Sigma, Lean Manufacturing.

 Knowledge of ISO13485, 21 CFR 820 (FDA).


Education

ü  Professional engineering degree.

ü  Minimum 5-year experience at engineering level.

English (intermediate level)
Devicor Medical Products, Inc. is an equal opportunity employer. 

As a rapidly growing company, Devicor Medical Products, Inc. is always interested in talented people. We are currently accepting resumes from qualified candidates expressing interest in the openings listed. Due to the large number of inquiries we are not able to accept unsolicited resumes for unspecified or non-posted positions. Our postings change regularly, please check back again.

To Apply:
Devicor Medical Products, Inc. is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company. With success in mind as the ultimate goal, we strive to create and provide an environment that offers challenging, stimulating and financially rewarding opportunities. As an employee of our organization, you will be consistently challenged to deliver your best.

If you are ready for this challenge, complete the on-line application and submit your resume for consideration. If your background and skills are suitable for consideration for this position, you will be contacted for further information.

Devicor Medical Products, Inc. pays salaries commensurate with market value, and provides exceptional benefits.



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.