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11197
PERM

Quality Specialist II

Location: Burlington, Massachusetts

Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:

 

Job# bh11197

 

Quality Specialist

  • They must have ERP experience, preferably Great Plains, but SAP or another one is fine. Must be advanced excel user.

Responsible for the continuous improvements of the Training and Documentation programs. Documentation includes generation and storage of Quality Records which includes change requests, procedures, specifications, protocols, reports, drawings, electronic and hardcopy archives, and notebooks. Training includes management of the training program and associated documentation.

Essential Responsibilities:

The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.

• Responsible for the creating, maintaining, and managing the document management system along with driving process improvements.

• Manages the quality systems databases for SOPs, training, change controls, and Deviations.

• Responsible for processing and tracking documents in change system and provides metrics.

• Routing, releasing and issuance of controlled documents to ensure internal satisfaction and conformance to company requirements.

• Resolve deficiencies, inconsistencies and discrepancies in documentation identified for change and reviews change documentation for completeness and accuracy, including all aspects of the Document Change process.

• Ensures all Quality System records are controlled in a manner which ensures integrity and accessibility including photocopying/scanning of documents, as applicable (Fabrication Files, Training records etc.)

• Creates and maintains new documents with input from Manufacturing, Engineering, and Marketing.

• Responsible for data entry for new part numbers, part revisions and bills of material into ERP system.

• Maintains electronic Documentation Distribution, Redline Documents, Lab Notebook and Deviation logs.

• Manages the proper storage and filing of Instrument Fab files, Reagent Kit formulation sheets, Repair Kit Fabrication files, Deviations and, Lab Notebooks while keeping an archive log.

• Maintains employee training database and provides reports of training completion to individual managers and departments

• Drives individual and group training sessions for system users on making document changes and reviewing electronic references copies of documents.

• Ensures new employees are trained on SOPs per specific job function

• Ability to demonstrate understanding of and ability to interpret US and international GxP regulations

• Assist with file migrations, audits and perform administrative tasks as needed.

 

Non-Essential Responsibilities: In addition to the essential responsibilities listed above, the employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

• Writes quality management system procedures

Qualifications:

• Bachelor’s Degree in Business Administration preferred.

• 5 years of experience in Quality, with at least 2 years’ experience in a similar role.

• Detail oriented and able to organize and lead processes.

• Must be able to follow instructions and established guidelines to perform the functions of the Document Control and Training

• Good written communication skills and time management skills

• Microsoft Word, Excel, and Access capability, including the ability to create reports

• ERP experience required, preferably Microsoft Dynamics Great Plains, including the ability to create reports

• Experience with medical devices is desired.

• Experience working in an ISO and/or GMP environment is desired.

• Proven problem-solving skills is a must.

• Must be authorized to work in the US without sponsorship now or in the future

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

                  

Duration:    Permanent

 

Rate            75K.

 

Locations:   Woburn, MA

 

Contact Info:                                                                                                                                                                            

 

ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776

jobpostings@csetalent.com