Quality Systems Specialist

Akkodis is seeking a Quality Management Systems Specialist role is a Contract with a client located in Victor NY 14564, Ideally looking for applicants to have a solid background in Quality Engineering, ISO-13485, CAPA. would come as a big plus.Pay Range: $35-$40/hr. W2 The pay may be negotiable based on experience, education, geographic location, and other factors.ResponsibilitiesActs 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 CooperVision policies and procedures. SME for Quality Assurance in both Global Processes. 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 CooperVision QMS at the site.Manages Training positions and roles in Agile for functional departments residing under the CooperVision 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.Communicates information effectively to and from other departments with the QA team.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.Performs other assignments related to the department as directed by Leadership.CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements. QualificationsKnowledge, Skills and Abilities:Excellent written, oral, and interpersonal communication skillsHighly self-motivated, self-directed and attentive to detailWell organized and detail oriented, strong data entry and analysisHighly adaptable, flexible and willing to accept new ideas, processes and proceduresExcellent analytical and problem-solving skills, with strong attention to detail. Ability to drive to root causeAbility to effectively prioritize and execute tasks, and meet project deadlines in a fast-paced environmentWorking knowledge of Microsoft Office Suite. Experience with Agile preferredPossesses skills to utilize the concept of continuous improvement, change management and employee teams. Ability to work with a diverse workforce Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices. Ability to enforce standards (QSR, CVI, etc.) and standardize global processesWork Environment:Normal Office environmentAbility to perform light to medium physical work and standing for long periods of time, if required depending on the taskExperience:2-3 years of experience with Quality Assurance requiredLead auditor experience preferred Medical Device industry experience preferredEducation:Bachelor’s degree required in related field; or an equivalent combination of education and experience is requiredIf 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.Equal Opportunity Employer/Veterans/DisabledBenefits offerings include but are not limited to:• 401(k) with match• Medical insurance• Dental Insurance• Vision assistance• Paid Holidays OffTo read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.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