Quality Management Systems Specialis - Akkodis : Job Details

Akkodis is seeking a Quality Management Systems Specialist for a contract job with a client in Rochester, NY. Must hold a Bachelor of Science degree in an Engineering field to be considered for this position. You will be responsible for conducting required Quality Assurance activities with local and global departments. You will also revise and at times create Standard Operating Procedures (SOP's), Work Instructions (WI's) and other controlled documents in collaboration with process owners and subject matter experts.

Rate Range: $30/Hr. to $40Hr.; The rate may be negotiable based on experience, education, geographic location, and other factors.

Quality Management Systems Specialist job responsibilities include:

• Acts as the Quality Assurance representative and participates with cross functional teams on significant Packaging and Labeling projects (example. mass change for regulation update).
• Acts as the QA approver and change analyst for Packaging and New Product Launch Change Orders (PCO and NPLCO).
• Provides guidance and is the QA lead on process requirements to ensure compliance with change control regulations and policies and procedures.
• Acts as final QA review prior to execution of new product launch. Responsible for ensuring all requirements are met prior to final release.
• Lead in continuous improvement efforts to streamline the QA review in above mentioned processes.
• Acts as change analyst for Document Change Orders (DCO's) and any required Deviations for functional departments residing under the QMS at the site.
• Manages Training positions and roles in Agile for functional departments residing under the QMS at the site.
• Reviews and participates in implementation of global document changes document required for the site.
• Regularly provides status and updates to QA Management regarding state of Packaging and Labeling QMS data and continuous improvement projects.
• Investigation, lead, coordinate, reviews and approvals of corrective and preventative action (CAPA) and nonconformance's (NCR).
• Assists with internal and process audits to verify conformance with standard operating procedures. This will include revising and or creating SOPs as needed. Conducts internal audits in any of the Rochester facility as required.
• Data entry and analysis into computer-based collection systems as required (Access, Excel & Agile).
• Performs archiving (as necessary) as it applies to quality records for the site. May assist in all aspects of record retention and retrieval. May act as Administrator for record retention activities.
• Provides eQMS and required QSR training for employees at the site. Applies knowledge of Good Manufacturing Practices (GMP) regulations and industry standards as well as ISO general guidelines.

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Desired Qualifications:

• Bachelor of Science Degree in an Engineering field is required.
• 3 years related experience required.
• Experience working in a medical device industry is required.
• Experience with Auditing is required.
• Experience with CAPA is required.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at 585-###-#### or [email protected].

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance