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Quality Technician: Medical Device History Records
Ref No.: 18-30041
Location: Rochester, New York
Position Type:Contract
Shift:First
Job Category:Quality Assurance
Benefits:401K, Dental Insurance, Medical Insurance
*1 year contract position with additional opportunity based upon performance and continued business need*

Qualifications:

The Responsibilities The Quality Technician is responsible for assessing the completion and adequacy of the Device History Record (DHR) to support the release of customer product. Duties and Responsibilities include but are not limited to:
• Reviews Device History Record (DHR) data entries for accuracy, completeness and compliance with specifications as per applicable departmental procedure(s) for review of quality records.
• Records and escalates exceptions to DHR in the applicable quality management systems.
• Performs QA Review and Releases product through a final usage decision in SAP so that the product can be shipped for customer use.
• Maintains a record of DHR errors and generates nonconformance records when necessary to alert Quality Engineers and other applicable personnel of any issues.
• Assists with the implementation of revisions, corrections and changes to procedures and methods.
• Observes discussions with quality, engineering and other relevant departments to learn about corrective actions for reoccurring problems.
• Ability to summarize data and coordinate with manufacturing supervisors the efficient/timely release of product.
• Observes and participates in discussions with quality, engineering and other relevant departments to learn about corrective actions for recurring issues.
• Must be detail oriented having the ability to work both independently and as a part of a dynamic team. • Follows detailed procedures documented in SOP's, work instructions, forms and on check lists.
• Strong documentation and organizational skills are required.

The Individual • Requires a minimum of a High School Diploma or GED and 2 years related work experience, preferably in a regulated environment. • Strong communication skills, both verbally and written is required. • Ability to follow detailed procedures documented in SOP's, work instructions, forms and on check lists. Follows compliance requirements and has knowledge of GMPs. • Microsoft Office (Outlook, Word, Excel, Access). • Strong attention to detail • Ability to work in a highly matrixed organization • Must be a highly flexibly individual who can work well in an environment with defined production deadlines • Preferred competencies include: SAP experience • ASQ or industry related certifications, QERTS Experience, LIMS Experience, and OTIS Change Author Experience. • Knowledge of blood analyzer equipment is preferred. • Ability to be flexible in covering manufacturing shift hours • Process Excellence knowledge is preferred. 

Responsibilities: 
The Responsibilities The Quality Technician is responsible for assessing the completion and adequacy of the Device History Record (DHR) to support the release of customer product. Duties and Responsibilities include but are not limited to:
• Reviews Device History Record (DHR) data entries for accuracy, completeness and compliance with specifications as per applicable departmental procedure(s) for review of quality records.
• Records and escalates exceptions to DHR in the applicable quality management systems.
• Performs QA Review and Releases product through a final usage decision in SAP so that the product can be shipped for customer use.
• Maintains a record of DHR errors and generates nonconformance records when necessary to alert Quality Engineers and other applicable personnel of any issues.
• Assists with the implementation of revisions, corrections and changes to procedures and methods.
• Observes discussions with quality, engineering and other relevant departments to learn about corrective actions for reoccurring problems.
• Ability to summarize data and coordinate with manufacturing supervisors the efficient/timely release of product.
• Observes and participates in discussions with quality, engineering and other relevant departments to learn about corrective actions for recurring issues.
• Must be detail oriented having the ability to work both independently and as a part of a dynamic team. • Follows detailed procedures documented in SOP's, work instructions, forms and on check lists.
• Strong documentation and organizational skills are required.

Pay Rate: $19.00 per hour
Drug and background screenings required


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