Implement and updates quality procedures and controlled formats.
- Implement/improve inspection methods.
- Define and clarify inspection criteria.
- Ensures to be in compliance with the current procedures of the department, particularly in assigned areas.
- Ensures to be in compliance with Good manufacturing practices in assigned areas.
- Provides support to make decisions about rejected material under an MRDR (Rejection Form).
- Prepares and distributes the weekly rejection report from production areas (MRDR Report).
- Prepares and distributes the monthly rejection report from materials (Materials Review Board - MRB).
- Performs personnel movements in TRESS system (shift, area, schedules, permission).
- Review payroll weekly.
- Schedule and submit for approval employee vacations that require it.
- Provides equipment that employees need to perform their work.
**Job Requirements**:
- Bachelor's degree in Industrial/Mechanical Engineering or related area.
- Knowledge in the Medical Device Quality Systems regulations ISO 13485, ISO 9001 and GMP's.
- 3 to 5 years related experience in the Industrial industry (medical industry is a plus.)
- Certificate/related experience as an Internal Auditor.
- Certificate/related experience as a CQE (Certified Quality Engineer) is a plus.
- Experience in the elaboration and audits to (CAPA's.)
- Strong written and oral English communication skills (70%.)
- Knowledge of Lean Manufacturing tools.
- Strong and effective team player.
- Effective communication with ability to lead and influence people.
- Visa and willing to travel.
**Operating Company**:
Spark
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.