Job Description
Job DescriptionDescription:
Job Summary
Manages and oversees all aspects of the Quality Assurance, Quality Engineering, and Quality Control functions globally by setting, directing, and overseeing policies on quality standards and regulatory compliance; interpreting new quality and regulatory requirements/trends as they relate to all operations; and supporting and managing the firm’s relationship with external regulatory agencies. Responsible for guiding others within the organization on quality management system and regulatory compliance basics, ensuring understanding and compliance with updated requirements including US FDA, EU MDD/MDR, and other international regulatory bodies. Job holder to promote and adhere to the company values of quality and compliance with current legislation. This position is an in-office position in the Headquarters in Huntersville, NC USA.
Essential Job Functions
The job holder will undertake some or all of the following responsibilities:
- Build, lead and develop a high-performing and collaborative team of QA, QE, and QC personnel focused on local and global compliance
- Contribute to and drive the global strategies for Quality and QMS alignment
- Work with leaders across the business to develop strategies and plans to fulfill the mission and goals of the business while maintaining compliance with quality standards and regulatory requirements
- Lead efforts in continuous improvement, including lean quality processes and risk-based decision-making
- Practice and mentor others to approach situations with a risk-based approach
- Drive a culture of compliance through influence, relationships, and partnership with cross-functional leaders
- Collaborate with Operations, Engineering, Regulatory, and Supply Chain to ensure design transfer, manufacturing, and distribution activities meet quality standards
- Apply various principles and techniques for developing and organizing teams and leading quality initiatives and continuous improvement within their function
- Facilitate meetings and aspects of projects. Assist in working through resistance to change and improvement
- Liaison with external organizations regarding Quality matters, including suppliers, Notified Bodies, external regulatory bodies, etc.
- Support firm’s product development process and programs with resources and Quality expertise
- Perform, and teach others to perform, root cause analysis of identified issues including identification of appropriate corrective and preventive action
- Ensure timely and effective closeout of non-conformances, complaints, and CAPAs
- Define and monitor quality metrics and KPIs; report quality performance to executive leadership
- Ensure effective implementation and maintenance of Quality System appropriate to the products manufactured by and for the company and compliant with the relevant requirements of FDA Quality System Regulations (21 CFR 820), ISO 13485, EU and UK Medical Device Regulations, as well as any other applicable global regulatory body regulations at multiple locations/sites
- Ensure the quality of the company products through the establishment, monitoring, and enforcement of a Quality Management System in compliance ISO 13485, EU and UK Medical Device Regulations and 21CFR820 requirements, as well as the requirements of any other applicable global regulatory body
- Review documentation to ensure compliance with the relevant requirements of FDA Quality System Regulations (21 CFR 820), ISO 13485, EU, UK Medical Device Regulations, and others as applicable
- Training of Quality personnel
- Perform formal and informal audits as necessary
- Oversee supplier quality management including audits of key vendors and partners, as necessary
- Provide support or lead audits as necessary including external audits, internal audits, or supplier audits
- Represent Quality in leadership meetings and strategic planning sessions
Requirements:
Qualifications
- University degree, preferred, or relevant experience
- Medical device industry experience of at least 10 years, with a minimum of 5 years within the Quality or Regulatory functions
- Minimum of 4 years of management experience
- Some experience with US FDA OTC drugs, combination devices and cGMP requirements (21 CFR 210/211) preferred
- Thorough knowledge of US, EU, UK, and other medical device regulations, as well as ISO 13485 and ISO 14971, MDSAP requirements
- Effective Quality leader with a demonstrated ability to build, lead, and train a team of Quality professionals
- Proven ability to work in a fast-paced, growth-oriented environment
- Ability to work with cross-functional partners to drive a culture of compliance
- Computer literate and experienced in Microsoft Office applications
- Must fit within the Safeguard Medical culture
Competencies
Demonstrates (1) ownership and accountability; Demonstrates the ability to: plan, execute, control and deliver; (2) communicate effectively both written and verbal; (3) Team-orientated personality with the ability to lead and influence others effectively without authority while creating and maintaining a positive environment; (4) Understanding of change management, conflict resolution and team dynamics; (5) respect for people with a desire to develop junior-level team members including coaching in 1:1 and team settings; (6) ability to identify project and business risks and create mitigation strategies; (7) ability to independently make sound decisions with available information, employing a risk-based approach when appropriate; (8) Effective at leading cross-functional initiatives.
Physical Requirements
Performing the duties of this job regularly involves: (1) sitting, (2) standing; (3) walking; (4) hearing/listening (5) repetitive hand movement; (6) vision requirements - close vision, adjust focus, color code
Mental Requirements
This position requires the ability to: (1) maintain an appropriate work pace; (2) comprehend and follow instructions; (3) exercise logic and reasoning; (4) organize and prioritize; (5) read; (6) compose written communication; (7) communicate verbally; (8) problem solve (9) make decisions; (10) count and compute (11) analyze and interpret data; (12) multi-task/re-direct; (13) experience numerous interruptions, (14) This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations
Other Requirements
(1) Business travel required up to 15% of the time; (2) Must fit within the Safeguard Medical culture
Work Environment
The noise level in the work environment is usually (1) quiet to moderate.
Hazards in the warehouse environment are: (1) moving machinery; (2) trip hazards
This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned, and activities may change at any time with or without notice.
Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.