Senior Quality Systems Specialist - Amtec Human Capital Inc

Role: Senior Quality Systems Specialist 
Location: Illinois
Duration: Permanent

Salary: $110,000-$115,000K


Job Description:

We are establishing a new department and seeking an individual to join our team as a Senior Quality Systems Specialist in a manufacturing company, specializing in the medical device industry. This role reports to the Manager of Quality Systems and holds supervisory responsibilities, particularly overseeing the Customer Complaints program.

You should have a hands-on experience in setting-up quality assurance systems across various aspects of medical device operations, sales, and engineering with specific expertise in ISO 13485 as you will be collaborated across departments and will focus on working through all departments as a team in conducting Quality reviews, validation, CAPA, as well as Internal and External Audits. Additionally, we are looking for someone capable of delivering presentations to C-suite leadership. 

Responsibilities:

• Provide leadership for improvement projects, determine problem areas and provide solutions.
• Responsible for Customer Complaints Program.
• Maintain and improve the Quality Management System (QMS) to comply with all applicable requirements for medical devices (i.e. 21 CFR 820 Quality System Regulation; ISO 13485:2016; ISO 14971:2019).
• Utilize knowledge and expertise to identify, solve and document problems and risks within the quality system.
• Conduct and support training (i.e. QSR, GMP’s, Internal Auditing, FDA Inspections, Quality Reporting, Customer Complaint Management, Document Control, etc.).
• Conduct Internal Audits and support External Audits (i.e. FDA, UL, etc.)
• Serve as a Subject Matter Expert (SME) for colleagues.
• Support QARA Management in conducting Management Reviews and in developing quality objectives.
• Manage/Support Customer Complaint Management, Internal Audit, Risk Assessment, Document Control and CAPA processes.
• Support data collection, quality report preparation and metric creation/deployment.

Qualifications:

• Must have a Bachelor’s Degree in Science or in technical field.
• Should at least have 5 years experience in the medical device industry.
• Strong experience working with a Quality Management System (i.e. Master Control Platform; Qumas Platform, etc.) and its elements.
• Solid experience working in a Class I and Class II Medical Device environment.
• Extensive knowledge of medical device regulations/standards including ISO – 13485
• Knowledge of ISO 14971:2019 (Risk Management for Medical Devices).
• Experience in Design Controls and conducting training courses.
• Experience hosting and supporting external audits (i.e. FDA Audits, Customer Audits, Corporate Audits, UL, etc.).
• Certifications preferred – i.e. Internal Quality Auditor, Quality Systems/Management, Risk Management.
• Knowledge of Lean/Six Sigma process improvement approaches and techniques.
• Self-motivated, team player, confident, problem solver, energy, enthusiasm, creative, manage under pressure.

Benefits:

 - In house for most part but will consider 1 or 2 days remote a week after six months of training.

 - Ideally find a local candidate but MIGHT negotiate for sign on bonus if an exceptional fit to the role.

Why is This a Great Opportunity?

Emphasizes the importance of maintaining a healthy work-life balance and incorporating enjoyment into daily activities, recognizing that this position is not merely a job, but rather an opportunity for personal fulfillment and advocacy.