SOL-MILLENNIUM Medical Group is an entrepreneurial global healthcare company dedicated to the research and development, manufacturing, and distribution of high-quality medical devices that support best clinical practice while protecting healthcare workers and their patients from the risks associated with needlestick injury.

Sol-Millennium sells a broad range of medical products such as needles, syringes and blood collection devices to hospitals, animal health groups, medical supply companies, government health departments and scientific research facilities in 40 countries around the world. We operate facilities in twelve countries, including R&D hubs in Switzerland and China. At the outset of the Covid-19 coronavirus crisis, Sol-Millennium introduced a broad range of PPE and related products for use by hospital professionals, patients, first responders and other community organizations. Sol-Millennium has also proudly supplied over 2 billion syringes and needles for use in vaccination campaigns around the world.

Sol-Millennium is seeking a Quality Systems Manager to ensure the overall effectiveness of the quality management systems for Sol-Millennium. The manager is responsible for continually assessing the quality management system and keeping it compliant to the global regulatory requirements and applicable standards as necessary via quality planning, gap assessment and initiating corrective actions (where applicable).

This role will be based out of our newly renovated downtown Chicago headquarters in a hybrid capacity.

Responsibilities:

• Initiate quality plans for any foreseeable changes in regulatory requirements, which could impact the efficacy of the current quality management system.
• Lead the corrective action initiatives to remediate the gaps identified during internal and external audits.
• Ensure the Quality Management System is compliant to 21 CFR 820, EU MDR (2017/745), MDSAP requirements.
• Responsible for performing trend analysis on critical QMS elements (i.e. CAPAs, Complaints and NCRs) to suggest appropriate and timely action on unintended trends.
• Lead cross-functional teams to provide guidance on regulations.
• Keep the stake holders apprised of changes to the regulations.
• Execute quality plans with cross-functional support.

Required Qualification:

• 5-7 years of leadership experience in the Medical Device industry.
• Bachelors’ or master's degree in engineering or another applicable field.
• Experience in leading internal and external audits including FDA inspections.
• Demonstrated expertise in US FDA Regulations (e.g., 21 CFR 801, 21 CFR 803, 21 CR 807, 21 CFR 820) and ISO 13485: 2016.
• Knowledgeable in MDSAP audit requirements.
• Knowledgeable in Risk Management Standard ISO 14971: 2019.

Preferred Qualification:

• ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Quality, Engineer, etc.).
• Knowledgeable in product standards pertaining to needles and syringes, blood collection systems.
• Have assisted in the development of Technical Files/STED documentation.
• Experience in Change Control (ECRs, ECOs etc.) process.
• Experience in a Design and Development project(s).

Sol-Millennium requires all employees starting in this position to be fully vaccinated against Covid-19. Proof of full vaccination is required on start date.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. The level of this position will be based on the final candidate’s qualifications.

Sol-Millennium is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.