Job Details
This position works within the Quality Department in Bloomington, MN. They will collaborate frequently with Receiving, Inventory, Quality Engineering, and Purchasing departments.
The Quality Inspector will perform inspections on purchased materials as well as in-process production devices/documentation in accordance with defined policies and procedures. Support of Quality Department activities outside of normal day to day inspection will be required as necessary, including supporting deviations and internal audits.
Essential Functions (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
- Inspect incoming materials and literature by confirming specifications, conducting visual inspections, measurements, and rejecting and returning unacceptable materials.
- Inspect in-process production by confirming part and customer specifications, conducting visual inspections, measurements, reviewing GDP (Good Documentation Practices) and completing inspection reports.
- Perform inspection according to inspection plan and procedures.
- Document inspection results in reports and logs and input data into software system.
- Read and understand basic drawings and specifications
- Manage and review RI (Receiving Inspection) procedures and incoming inspection records for accuracy and completeness on an ongoing basis to maintain compliance with ISO and QSR requirements
- Interact with Receiving, Inventory and Purchasing to determine daily priorities as directed by inventory demands.
- Transact and physical quarantine all rejected parts into the MRB (Material Review Board) location
- Maintain MRB accuracy.
- Responsible to initiate and support NCs.
- Interact with Purchasing and Planning to attain RMA number and other communication letters to support the closure of NCs.
- Must be able to utilize required computer software (ERP, PLM, QMS, etc.) to complete task.
- Maintain area organization using 5S standards.
- Perform UDI Barcode Verification.
- ROBAR/GUDID uploading.
- Operate Production Scanner to digitalize DHR (Device History Record).
- Perform other duties as requested by Quality Engineers and Manager.
Competencies (Knowledge and Skills needed for this position.)
- Follow the HR policy including all company and department policies and procedures.
- Basic understanding of Microsoft Office Programs
- Capable of using inspection equipment such as digital caliper
- Organized and Detail Oriented
- Perform responsibilities as directed achieving desired results within expected time frames and with a high degree of quality and professionalism.
- Follow good safety practices in all activities.
- Establish and maintain positive and productive work relationships with all staff, customers, and business partners.
- Demonstrate the behavioral and technical competencies necessary to effectively complete position responsibilities. Take personal initiative for technical and professional development.
- Safeguard sensitive and confidential Company information.
- Prepare for in advance and coordinate with the buyer rushed incoming materials
Desired QualificationsRequired Education:High school diploma or equivalent
Preferred Education:Associate Degree with a quality emphasis Certified Quality Inspector through ASQ
Experience:Experience working in ISO 9001 or ISO 13485 certified facility preferred Experience as Quality Inspector in medical device manufacturing preferred
Other InformationDirect reports:n/a
Indirect reports:n/a
Working Environment:Open office environment, located near a manufacturing facility
Physical Demands:Sitting, standing, lifting (no more than 40 lbs)
Position Type and Expected Hours of Work:Full time position. Working Monday through Friday, with potential overtime and weekend support if necessary
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Equal Opportunity EmployerGN Hearing is an equal opportunity/affirmative action employer committed to cultural diversity in the workplace. GN Hearing openly supports and is fully committed to the recruitment, training and promotion of all individuals, without regard to race, color, creed, religion, national origin, ancestry, sexual orientation, disability, age, gender, maternity, marital status, status with regard to public assistance or any other classification protected by state, federal or local law or ordinance. Founded in 1869, GN group today operates in more than 90 countries across the world and has more than 6,000 employees. View The EEO is the Law poster and its supplement.
E-VerifyGN Hearing / ReSound participates in E-Verify. View the E-Verify poster here. View the Right to Work poster here.
Disability AccommodationIf you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ...@gnresound.com. This email is provided for the purpose of supporting applicants who have a disability that prevents them from being able to apply online. Only emails received for this purpose will be returned. Emails left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
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