Quality Engineer II (MDR Project)
Indispensable Requirements:
Education
- Graduated from Industrial, Mechanical, Electrical, Electromechanical Engineering or related career.
Knowledge:
• Bilingual (English / Spanish)
• Reading & Interpretation of drawings
• Basic Project Management
• Expertise in MS Office
• Knowledge of GMP, ISO and FDA regulations.
• DMAIC "Problem Solving"
• Data analysis
• Basic statistic knowledge
• Risk assessment
• PFMEA
• Statistical analysis, Minitab and SPC.
Experience:
- 2+ years’ experience in medical device manufacturing, pharmaceuticals, or other regulated industry.
Nice to Have
- Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations.
- Experienced practitioner of continuous improvement methodologies with Lean Six Sigma Green or Black Belt.
- Advanced statistical data analysis skills.
- Experience working with cross-functional and international teams.
- Ability to manage multiple projects.
- Able to work independently, as well as in a team environment.
- Ability to educate stakeholders, customers, and management.
- Working knowledge of GD&T
- Working knowledge of R&R and TMV.
Competences:
Strong verbal and written communication, Autonomy, innovation, Results Orientation, Effective working with cross-functional teams, Teamwork and Influence, Project Planning and Organization, Problem Solving, negotiation skills, analytical skills.
Benefits:
Competitive Salary, Performance Bonus, Supplemental Insurance, Lunch Grant, Training & Development, Life Insurance, School Bonus, Option Buy MDT Shares, among others.
Position Details:
• Location: San Isidro Free Zone, Santo Domingo Este. Dominican Republic
• Business Hours: Regular, 8:00 AM to 5:00 PM
About Medtronic
Together, we can change health care around the world. At Medtronic, we push the boundaries of what technology, therapies, and services can do to help relieve pain, restore health, and extend life.
We challenge ourselves and others to make tomorrow better than yesterday. It's what makes this an exciting, challenging and rewarding workplace. We want to accelerate and advance our ability to create meaningful innovations, but we will only succeed with the right people on our team. Help us shape the future.
Physical work requirements
The above statements are intended to describe the general nature and level of work performed by employees assigned to this position, but do not constitute an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the one-day work section are representative of what an employee must fulfill to successfully perform the essential functions of this job. Reasonable accommodations can be made to allow people with disabilities to perform essential functions.
Medtronic's policy is to provide equal employment opportunities (EEO) to all persons regardless of age, color, nationality, citizenship, physical disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, state with respect to public assistance, veteran status or any other characteristic protected by federal, state or local law.
