Quality Systems Manager, BIOTRONIK Neuro

Biotronik•Oswego, IL

2d•Remote

About The Position

BIOTRONIK is seeking a Quality Systems Manager to support and maintain the Quality Management System (QMS) and ensure compliance with applicable medical device regulations and standards. The role leads Quality Systems activities supporting internal quality systems, product quality, and distribution. It partners with cross-functional teams to ensure processes meet regulatory requirements and drives continuous improvement throughout the organization. The successful candidate will provide technical leadership, foster collaboration, develop company capabilities, and contribute to departmental and organizational quality objectives. The position operates primarily in a professional office or remote office environment, with occasional participation in meetings, supplier management, and events as needed. It is a full-time role with standard working days Monday through Friday; hours may vary depending on the time zone supported. Occasional evening and weekend work is required as job duties demand. Limited travel is anticipated on an occasional rather than routine basis for assigned projects, meetings, or events. The position has no direct reports but leads cross-functional contributors through influence and expertise.

Requirements

Bachelor's degree in Engineering, Computer Science, Physics, Life Sciences, or a related technical field.
5–10 years of experience in a medical device, pharmaceutical, or biomedical quality environment.
Experience supporting quality engineering activities within a regulated product environment.
Strong understanding of risk management, supplier quality, complaint management, and quality systems requirements.
Ability to effectively communicate technical and regulatory requirements across multiple organizational levels.
Familiarity with configuration/change management practices.
Demonstrated ability to influence cross-functional stakeholders and manage competing priorities.
Strong analytical, organizational, and problem-solving skills.
Excellent written and verbal communication skills.
Working knowledge of FDA regulations, including 21 CFR Parts 11, 801, 803, 806, 807, 812, 820, 822, and 830.
Working knowledge of ISO 13485 and quality management systems for medical devices.
Understanding of GMP requirements.
Knowledge of quality processes across the life cycle.
Understanding of statistical methods and quality improvement tools.
Strong engineering and technical aptitude across hardware, software, and systems development environments.

Nice To Haves

Advanced degree.
Experience supporting regulatory submissions, audits, and inspections.
Experience participating in regulatory inspections and third-party audits.
Certified Quality Manager, Engineering, or Auditor (ASQ CQM, CQE, etc.).
ISO 13485 lead auditor or ASQ CQA.

Responsibilities

Manage Quality Systems activities in accordance with company policies and applicable regulations.
Serve as a primary point of contact for Quality Systems with internal stakeholders and support interactions with corporate quality, regulatory, operations, and clinical organizations.
Serve as a point of contact for physician communications regarding returned product analysis test results.
Lead and support cross-functional teams to ensure product quality and distribution activities comply with applicable regulations, standards, and company procedures.
Implement, maintain, and continuously improve quality processes, procedures, and systems, including internal audit, change management, supplier quality, clinical research quality, complaint handling, and document control processes.
Manage external contract design and manufacturing (CMDO) organizations in partnership with the sourcing organization.
Monitor departmental goals, metrics, and performance indicators to ensure achievement of quality objectives.
Support resource planning and provide input into company and departmental budgets and staffing requirements.
Promote awareness of regulatory, quality, and customer requirements throughout the organization.
Identify and communicate potential quality and compliance risks and recommend appropriate actions.
Support maintenance and improvement of FDA 21 CFR Part 820 QMSR, ISO 13485, and other applicable quality system requirements across internal and external sites.
Lead internal and external audits and support inspections by regulatory agencies and notified bodies.
Drive continuous improvement initiatives related to quality systems processes and compliance activities.