Project Manager, Quality

Job Summary:

The Project Manager, Quality will provide support across the intra-departmental Quality functions, including Quality Compliance, Quality Assurance and Product Assurance. This position will support ongoing corporate projects with a focus on sustaining and improving both quality systems and products. The project manager will be given the opportunity to interact with the company's quality and compliance management as well as all complimentary departments in the achievement of organizational goals. This position will be given the opportunity to develop into a quality manager with responsibility for the support of quality systems implementation and management. The other developmental pathway is product based. A quality assurance manager with a focus on product assurance, quality engineering and a more technically focused area of operation. The individual must have exceptional organizational abilities and be able to multi-task in order to provide support on quality initiatives and projects. This person must also be detail-oriented and able to provide hands-on, individual contribution as needed to meet Quality department goals and objectives.

Duties & Responsibilities:

• Support the implementation of process changes preparing for EU MDR compliance and ongoing compliance with US FDA regulations and international standards. This includes coordinating project sub-tasks, updating procedures and the development of new processes;
• Review changes to company documentation and confirm adequacy and completeness in documentation;
• Review Change Orders and determine impact of changes;
• Represent Quality department in project meetings and provide quality/compliance guidance;
• Generate/update quality system procedures as required (i.e. SQP/SOP's);
• Develop and maintain up-to-date knowledge on regulatory compliance requirements, especially FDA and EU requirements;
• Coordinate with international quality team members on quality system updates and improvement projects;
• Provide project team leadership as necessary;
• Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• • Must have working knowledge of quality system and practices;
  • Must be able to provide guidance to functional teams on quality requirements;
  • Experience in Quality Systems per ISO 13485;
  • Ability to work in a Project Team Environment;
  • Computer Proficiency with MS Office (Word/Excel/Access/Outlook);
  • Excellent verbal and written communication skills;
  • Excellent prioritizing, organizational, and interpersonal skills;
  • Excellent documentation skills including detail-oriented, record maintenance/ tracking and understanding of document traceability;
  • A detail-oriented individual, with a "can do" attitude, and the ability to work in a team environment, as well as individually (with minimal supervision);
  • Ability to work in a fast-paced environment, with multiple tasks/projects;

Preferred Qualifications:

• Experience in patient monitor systems, hospital-based products, software or electronic device products;

• Experience with EU harmonized standards;
• Experience interacting with regulatory bodies, such as the Notified Body;
• Experience with FDA/GMP requirements for medical device;

Education:

BA/BS Degree, or equivalent combination of education and experience is required. Graduate degree in Quality or Regulatory will be taken into consideration to offset a lack of professional experience.

Compensation:

The anticipated range for this position is $70,000 - $106,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

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.