Quality Engineer with EU MDR experience

Akkodis is seeking a Quality Engineer with EU MDR experience for a Contract job with a client in Albany GA. Ideally looking for applicants with a solid background in the Medical Device Manufacturing industry.

Pay Range: $40 - $45/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Please find the attached JD Below

JOB RESPONSIBILITIES INCLUDE:

• Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
• Act as an effective team member in supporting quality disciplines, decisions, and practices
• Work within a cross-functional team to identify and implement effective controls and support commercial design changes, specifically with regard to quality and risk management
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Perform regulatory standard assessments and support regulatory submissions to notified bodies
• Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Update and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)

Minimum qualifications:

• Bachelor’s degree in biomedical, Mechanical Engineering, or related field of study
• Plus 2 years of experience in design assurance, new product development, or related experience in a highly regulated industry
• EU MDR experience
• Supplier Quality Management
• Supplier Auditing experience
• Experience with documentation and Track wise digital
• Demonstrated use of Quality tools/methodologies
• Strong verbal and written communication skills
• Self-motivated with a passion for solving problems and a bias for action
• Effectively work and collaborate in a hybrid (onsite plus remote) environment

Preferred qualifications:

• Prior medical device industry experience, particularly with medical electrical equipment
• Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations
• Experience in managing multiple projects across multiple organizational disciplines

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Punit Pathak at 610 445 8219 or Punit.pathak@akkodisgroup.com.

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.

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 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