Quality Specialist

Akkodis is seeking a Quality Specialist for a 4 months Contract position with a client located in Germantown, MD

Pay Range: $35- $37.50/hr on W2 (The rate may be negotiable based on experience, education, geographic location, and other factors.)

Job Description - Experience

• Experience in Quality Management Systems (ISO 9001, ISO 13485 or other regulated industry).
• Proficient use of hand inspection equipment (i.e.; calipers, micrometers, plug/thread gages).
• Proficient using/programming Keyence Vision System.
• Proficient using MS Office products (Word, Excel, Outlook, etc.).
• Proficient using e-QMS and ERP.
• High level of attention to detail and organization.
• Hard working, quick learner.
• Excellent verbal, written and interpersonal communication skills.
• Able to multi-task and work independently. Ability to participate in cross-functional teams.
• Knowledge of Quality Concepts (e.g., QMS, Line Clearance, CAPA, Audits, GDP).
• Medical device or other regulated industry quality work experience (year ).
• Experience reading engineering drawings/schematics.

Responsibilities

• Completes QC inspection of Medical devices per procedures and SOPs.
• Completes incoming and final inspections of components per procedures, approved fabrication drawings, and material inspection plans.
• Completes inspection and nonconformance forms accordingly.
• Collaborates with Purchasing, Operations, and Quality to ensure nonconforming material is labeled and isolated to prevent use and approved material is part of inventory for job builds.
• Reviews DHRs for completion and accuracy.
• As required, manages the document control system.
• As required, coordinates and manages training records.
• As needed, assists with filing of records and supports external and internal audits.
• As needed, maintains technical documentation and DMR files as an output of the Change Control process.
• Follows relevant Quality Manual and SOPs and assists in ensuring regulatory requirements, industry standards, and company policies are implemented and met.
• As needed, assists Purchasing/Operations and Quality in managing Supplier Corrective Action Requests and CAPAs.
• As needed, assists with executing, filing, maintaining calibration equipment/logs/files.
• Works closely with operations and the business functions to ensure quality performance of product and processes.
• Participates in the creation and/or review of new or modified procedures.

Education/Qualification

• High School / GED required, bachelor’s degree preferred.
• Minimum of 3 years’ experience in a quality role for a medical device company; this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment.
• Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable.

If you are interested in this Quality Specialist job in Germantown, MD please contact Ishwar Gupta at (610) 230 7687 or Ishwar.Gupta@akkodisgroup.com. For other opportunities available at Akkodis go to www.akkodis.com

This position requires the use of information or access to facilities subject to the International Traffic in Arms Regulations (ITAR) and/or Export Administration Regulations (EAR). These regulations may limit access to controlled technologies: 1) to U.S. Persons, including U.S. Citizens, lawful permanent residents, and other narrow categories including some refugees and asylees, or 2) to certain foreign nationals that have received an export license.

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 with 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.

To 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 by 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