Quality Systems Manager, BIOTRONIK Neuro

BIOTRONIK; Lake Oswego (OR); Remote; USD 110,000 - 150,000; Full time

Job summary

BIOTRONIK is seeking a Quality Systems Manager to maintain the Quality Management System (QMS) and ensure compliance with medical device regulations and standards. The role leads quality systems activities across internal quality, product quality and distribution to support regulatory requirements and organizational goals.

The successful candidate will partner with cross-functional teams, drive continuous improvement, and provide technical leadership to strengthen quality capabilities across the

Qualifications

• Understanding of risk management and quality systems requirements.
• Experience with FDA/ISO quality regulations and audits.
• Ability to communicate regulatory requirements across levels.

Responsibilities

• Manage Quality Systems activities in accordance with regulations and company policies.
• Lead internal/external audits and support inspections by regulators.
• Drive continuous improvement of quality processes and systems.

Skills

Risk management

Supplier quality

Complaint management

Quality systems

Regulatory communication

Analytical skills

Problem solving

Education

Bachelor's degree in Engineering, Computer Science, Physics, Life Sciences

Advanced degree preferred

Job description

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

We are seeking a Quality Systems Manager to support and maintain the Quality Management System (QMS) and ensure compliance with applicable medical device regulations and standards. This role is responsible for leading Quality Systems activities that support internal quality systems, product quality and distribution.

The Quality Systems Manager will partner with cross-functional teams to ensure processes comply with regulatory requirements while driving continuous improvement initiatives throughout the organization. The successful candidate will provide technical leadership, foster collaboration, develop company capabilities, and contribute to achieving departmental and organizational quality objectives.

Essential Functions:

• 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 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.

Required Education And Experience

• Bachelor's degree in Engineering, Computer Science, Physics, Life Sciences, or a related technical field. Advanced degree preferred.
• 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.

Specific Knowledge & 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.
• Experience supporting regulatory submissions, audits, and inspections preferred.
• Strong engineering and technical aptitude across hardware, software, and systems development environments.

Preferred Education and Experience:

• 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

Supervisory Responsibilities:

No direct reports. Will lead cross-functional contributors through influence and expertise.

Work Environment:

This position operates primarily in a professional office or remote office environment, with occasional participation in meetings, supplier management, and events, as needed.

Physical Demands:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Regularly required to be independently mobile.
• Constantly operates a computer, mobile device, and other office-productivity equipment.
• Required to interact with a computer for extended periods and communicate effectively with coworkers.
• Must be able to travel to other office or event locations, as needed.

Position Type/Expected Hours of Work:

This is a full-time position. Standard days of work are Monday through Friday. Hours of work may vary depending on time zone supported. Occasional evening and weekend work will be required as job duties demand.

Travel:

Limited travel as needed for specifically assigned projects, meetings, or events; anticipated to be occasional rather than routine.

Location: Remote out of Lake Oswego, OR | Working hours: Full-time | Type of contract: Undefined

Job ID: 62801 | BIOTRONIK NRO INC. | USA

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.