Quality Technician II

MAIN PURPOSE OF THE ROLE
Provides independent evaluation of materials components and products per specific instructions and work process within the quality system. Quality and production support resource to ensure compliance with policies and procedures within an atmosphere of error prevention and continual improvement.

MAIN RESPONSIBILITIES
Responsible for compliance with applicable Corporate and Divisional policies and procedures.
Review material equipment and systems quality through examination inspection measurement or testing of raw materials components sub assembly final assembly packaging labeling and documentation.
Contributes to validation testing as defined on validation protocols with engineering guidance. Ensures that all evidence documentation complies with governing procedures.
Audits and verifies processes such as line verification or environmental conformity to prevent quality system and manufacturing impact.
Reviews and verifies compliance of documentation such as batch records reports of nonconforming materials inspection records.
Notifies supervision of issues or errors providing immediate response.
Identifies and segregates nonconforming material from the production line according to governing documents. Coordinates with the Quality Engineer to prepare and handle the material in and out of the designated quarantine area.
Executes Testing of samples as part of its daily activities with minor guidance from Quality Supervisor or Quality Engineer.
Executes product acceptance testing sampling inspection classification or disposal based on engineering dispositions. Ensures
that all evidence documentation complies with governing procedures.
Assists to set up train and certified new or transferred Quality Technicians.
Provides ideas for improvement in areas such as quality productivity and safety.
Inputs data to required systems. CATSWeb use is limited to run queries and/or input lots test data.
Could support collecting samples for environmental monitoring.

Required Qualifications
-Associates Degree ( 13 years) in science or technical field or an equivalent combination of education and work experience
- Minimum 2 years experience in related field- experience at medical devices companies or equivalent
- Communication skills in verbal and written in English.
- Excellent interpersonal skills.
- Basic to moderate math knowledge.
- Handles MS Word Power Point and Excel at a basic to intermediate level.
- Applies acquired knowledge of procedures and practices and a complete understanding of fundamentals in a functional area and working knowledge of other related disciplines.
- Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- Performs assignments usually in the nature of manufacturing environment requiring working independently or with minor supervision. May contribute in the design develop or modify area-specific processes or procedures.
- Additional assignments can be given with engineering supervision and will require considerable judgment and initiative.

Preferred Qualifications

- Experience with SAP

-Experience managing non-conformance issues

The base pay for this position is

In specific locations the pay range may vary from the range posted.

IC