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Sr. Quality Systems Specialist

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  • ID: 490835
  • Posted: 8/26/2021
  • Location: Norwood, MA
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 9 - 12 Months

Description

Acara Solutions is looking for a Sr. Quality Systems Specialist for our Client located in Norwood, MA.
  • The Sr. Quality Systems Specialist will participate in the management, governance, and execution of Quality Management Sub-Systems. 
  • Specifically, the person will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems Compliance regarding training, and Documentation Control (specifically Design History Files and SOPs). 
  • Additionally, this role will support specific quality improvement projects as required for QT and other business initiatives. 
  • Manage the daily POC Document Control Workflow within the Edgewater location.
  • Support the External Audit processes by participating as an SME for the Quality Document Process.
  • Support the monitoring and reporting of Quality Systems key performance indicators (KPIs).
  • Manage the daily Learn4U Training Workflow.
  • Assist with development and presentation of the POC new hire onboarding training program
  • Assist with development and presentation of the POC ISO 13485 training program.
  • Analyze complex quality trend data to identify and solve problems.
  • Designs and develops systems for recording, evaluating, and reporting quality data. 
  • Perform economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. 
  • Conducts complex audits and surveys to determine acceptability of quality controls
 
Pay and Benefits:
The salary for this position is $30.00 per hour
 
Job Requirements

 
Required Skills / Qualifications:
  • Associate's degree 
  • Minimum of 5 years' experience in Quality role within an FDA regulated industry 
  • Minimum of 2 years' experience in Quality Document Control as it relates to ISO 13485
  • Minimum of 2 years' experience in SAP PLM.
Preferred Skills / Qualifications:
  • The individual filling this role is expected to apply problem solving and interpersonal skills and be able to influence and drive results.
  • Medical device and diagnostics that includes experience with document control, training, and auditing processes. 
  • ASQ certifications such as CQA, Six Sigma, CQE, CQT or equivalent.
  • Prefer disciplines in English, technical writing, Science or similar. 
  • Possess ASQ or equivalent training in IVD / biomedical industry.
  • Applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. 
  • Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. 
  • Knowledge of organization's business practices and issues.
  • Primarily intra-organizational contacts and external contacts.
Additional Information:
  • Upon offer of employment, the individual will be subject to a background check and a drug screen.


Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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