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Job Description
Responsibilities:
- Lead and coordinate Corrective and Preventive Actions (CAPA) for Customer complaints, and process non-conformities.
- Communicate product quality issues, data analysis, trends, and/or other information to respective internal customers.
- Continual process reviews through the use of the defined process failure mode analysis (PFMEAs) documents.
- Develop processes and plans to identify trends and focus on customer complaints, and in-process non-conformances.
- Develop and define measurement equipment to evaluate and perform component inspections.
- Define effective control plans for warehouse to operations delivery of raw materials’ processes.
- Define, and lead continuous improvement projects focused on quality improvement, and cost reductions.
- Perform periodic audits of the accuracy and cleanliness of component storage locations and communicate results with appropriate warehouse personnel.
- Support the implementation and improvements for Good Manufacturing Practices (GMPs).
- Practice effective communications with peers, internal customers, suppliers and management on progress of activities.
- Maintain effective communication with Corporate counterparts.
Education:
Bachelor's degree in Manufacture, industrial or related degree to the position and responsibilities listed above
Work Experience:
1-3 years of Quality Control/Engineering experience
Medical Devices Experience (pharmaceutical, food or personal Care)
Internal / Lead Auditor ISO 13485:2016
Knowledge / Skills / Abilities
Bilingual (Fluent in English).
Effective communication
Able to collaborate effectively and respectfully with teams
Acts as a team member and facilitator
Self-motivated, demonstrated bias for action.
Lean manufacturing, Six sigma BB. GB
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
Skills Required
- Bachelor's degree in manufacturing, industrial engineering, or a related field
- 1-3 years of quality control or quality engineering experience
- Experience in medical devices, pharmaceuticals, food, or personal care
- Internal or Lead Auditor experience with ISO 13485:2016
- Fluency in English and bilingual communication ability
- Lean manufacturing and Six Sigma knowledge, including Black Belt or Green Belt
- Effective communication and collaboration skills
What We Do
All across America and the world, we help healthcare systems improve patient outcomes and reduce costs through clinical and financial solutions. As both a manufacturer and distributor of medical devices and supplies, we’re made up of problem solvers. Risk-takers. Big thinkers and doers.
