Sr Director, Quality Systems

Masimo Corporation; Mitchells Plain; On-site; USD 195 000 - 260 000; Full time

Job summary

An established industry player is seeking a Compliance Leader to oversee quality systems in the medical device sector. This pivotal role involves ensuring compliance with stringent regulations, managing a dedicated team, and driving continuous improvement initiatives. You will engage with various stakeholders, including regulatory agencies, to uphold the highest standards of quality and compliance. If you are a proactive leader with a passion for quality assurance and a track record of success in the medical field, this is an exciting opportunity to make a significant impact in a dynamic environment.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Maternity Leave

Flexible Spending Accounts

Employee Assistance Program

On-site Wellness Clinic

Fitness Center

Café

Qualifications

• 10 years of experience in Quality Assurance/Compliance in a medical device environment.
• Excellent communication skills with regulatory agencies and customers.
• Leadership and managerial skills in a compliance team.

Responsibilities

• Ensure effective implementation of quality systems: CAPA, Complaint Management, and MDR.
• Lead projects focused on improvements in quality compliance.
• Communicate with regulatory agencies and prepare compliance documentation.

Skills

Quality Assurance

Compliance Management

Project Management

Regulatory Standards

Communication Skills

Leadership

Education

Bachelor's Degree in Science

Bachelor's Degree in Engineering

Bachelor's Degree in Management

Job description

Job Summary

Responsible for providing compliance leadership in External Audits, CAPA, Complaints, Medical Device and Vigilance Reporting, Quality Systems Management. Ensures ongoing compliance with all applicable regulations and standards through the management, continuous review, and ongoing effectiveness of these systems. Develops and coordinates plans to identify, address, and mitigate potential risks to compliance in various processes implemented to support the Company's activities. Develops and mentors the quality compliance team, ensuring their competence, focus and productivity in relation to their specific job functions. Interfaces with individuals at all levels of the organization including other Masimo's facilities.

Duties & Responsibilities

• Maintain, support, and ensure effective implementation of the following quality systems: CAPA, Complaint Management, MDR and Vigilance Reporting, and Quality Systems Management.


• Ensure all areas of direct responsibility are compliant with the Company's Quality Manual, which includes but is not limited to the following regulations and standards: FDA 21CFR Part 820(QSR), 21 CFR Part 803 and 806, ISO 13485, Canadian Medical Device Regulation (SOR 98-282), Japan's Pharmaceutical and Medical Devices Act (PMDA), Brazil GMP, Therapeutic Goods Regulation (Australia), EU MDR (2017/745) and Medical Device Directive (93/42/EEC) (European) requirements.


• Responsible for project management activities, including leading specific projects focused on improvements in CAPA, Complaints, MDR and Vigilance Reporting, metrics reviews and the establishment of appropriate metrics, and Management Review.


• Responsible for preparing, maintaining, and updating procedures related to the quality compliance department. Serve as the Deputy Management Representative.


• Responsible for communicating (e.g., verbal and written) with regulatory agencies and customers.


• Ensure Management Representative and senior management personnel are adequately informed of the current performance of the quality system and any need for improvements.


• Provide Engineering and Quality with feedback from quality metric trend reviews and the output of analysis of data activities.


• Oversee administrative activities related to the management of the quality compliance team.


• Assist with coordination, hosting and ensuring proper follow up to external audits (e.g., FDA Inspections, Customer Audits, and ISO audits).


• Direct, plan, delegate and manage department budget and staff including hire, promote, demote, reclassify or terminate employees, write and conduct performance appraisals and disciplinary actions plans, make salary decisions (pay increases or new hire offers), create training and employee development plans, and handle department employee relations issues.


• Perform other duties and projects as assigned.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• 10 years of experience in Quality Assurance/Compliance in a medical device environment.


• At least 7 years of experience in managing direct reports at the manager level.


• Experienced in FDA 21CFR Part 820(QSR), 21 CFR Part 803 and 806; ISO 13485, SOR 98-282 CMDR (Canadian Medical Device Regulation), PMDA (Japanese), Resolution RDC #59 (Brazil), TGA (Australia), EU MDR and MDD (European) requirements.


• Excellent communication skills both verbal and written and the ability to interface effectively with personnel at all levels of the organization, with regulatory agencies and customers.


• Experience utilizing project management practices and methodologies.


• Well-organized and accustomed to maintaining excellent records.


• Leadership and Managerial skills.


• A "hands-on" individual who is capable and dedicated to getting the job done with minimal support and direction.


• Ability to travel ~25%/year.

Preferred Qualifications

Experienced in the management of quality and quality compliance related quality professionals.

Education

Bachelor's Degree in Science, Engineering, or Management required.

Compensation

The anticipated salary range for this position is $195,000 - $260,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 25% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center and Cafe. All benefits are subject to eligibility requirements.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

***NO AGENCIES PLEASE*** Thank you!

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