Medical Device Quality Engineer - Akkodis : Job Details

Akkodis is seeking a Senior Quality Engineer for a 6-month contract with a client in Buffalo Grove, IL 60089 (Onsite).

Title: Senior Quality Engineer - Medical Devices

Location: Buffalo Grove, IL 60089 (Onsite)

Contract: 6 months Contract

Pay Rate: $50-55/hr (The rate may be negotiable based on experience, education, geographic location, and other factors.)

Shift: 8 AM to 5 PM

Job Description:

• Experience: 8+ years in quality engineering and compliance within GMP manufacturing environments.
• Expertise: TPM development, internal quality systems, non-conformance handling, and continuous factory improvement.
• Compliance Knowledge: Strong understanding of 21 CFR Part 11, GMP, GDP, CAPA processes.
• Certifications Preferred: ASQ CQT, CQE, CQA; Six Sigma training in root cause analysis and problem-solving.
• Industry Preference: Prior experience in the medical device sector is highly desirable.
• Location: Local candidates preferred.

• A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system.
• Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
• Lead on-time completion of Quality Assurance (QA) engineering deliverables.
• Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems. Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems.
• Develop and lead training for QA systems. Influence and guide other team members with product review and analysis for QA activities.
• Maintain databases and record storage for QA systems. Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
• Lead meetings and communications for QA system information, concerns, and updates. Lead and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
• Track and proactively identify concerns manufacturing related complaints in alignment with SJM goals.
• Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues.
• Seeks out information independently and able mentor/lead other members of the organization on QA practices.
• Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables.
• Proficient as lead representative for presenting QA System to internal and external auditors. Investigate and resolve system nonconformances and concerns (defined during internal and external audits).
• As appropriate, leads in the completion of risk assessment, as related to QA systems. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. Operates a motor vehicle for trips to various Company sites and outside vendor, field, and customer locations; and to commute to various airports for airline.
• Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination.
• Activities also require significant use of voice and hearing for discussions with other employees. Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred) 5+ years technical experience Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills Prior medical device experience preferred ASQ CQT, CQE, CQA certification preferred Six Sigma root cause analysis/problem solving training and experience preferred.

If you are interested in this Senior Quality Engineer, job in Buffalo Grove, IL 60089 (Onsite), please get in touch with Udbhav Mathur at [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.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit .

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