Job Function Summary:
To provide support in carrying out all quality control functions to ensure that quality requirements are met, and perform quality control assignments as required.
- Performs in-process inspection/testing using approved test procedures, quality procedures and visual aids, and documents the results.
- Assists in data entry and performs various electronic transactions.
- Reviews Device History Records (DHRs) for completion and release of non-sterile product.
- Performs destructive testing.
- May perform other various QC testing as needed.
- Contributes to team effort by accomplishing related duties as requested.
- Inspection of some finished goods components per specifications using various measuring devices and documents.
- Provide input to documentation gaps, process improvements.
- Reacts to changing priorities and manufacturing inspection needs with little supervision.
- Assists in special projects as needed.
Required Knowledge, Skills and Abilities:
- Demonstrated ability to learn and understand QC core structure (inspection, testing, using various measuring devices, documentation of results, ability to follow DMR).
- Must have a high commitment to safety.
- The ability to perform repetitive tasks with a high level of accuracy.
- Able to work in a controlled clean environment.
- Self-motivated and able to take direction to perform all necessary duties.
- Ability to work cross-functionally with different departments.
- Capable of working in a fast paced, dynamic environment.
- Demonstrates ability to manage time efficiently.
- Strong analytical skills.
- High School Diploma or equivalent.
- Minimum of one year of experience working in a QC/GMP/GLP/Manufacturing environment.
- Good computer skills with MS Office applications (Word/Excel).
- Strong communication skills (English)
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions:
- Duties may be performed in a manufacturing/clean room environment.
- Personal protective equipment may be required as dictated by work environment.
- Must have the ability to work while standing/sitting for long periods of time.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. #LI-DNI
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
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