Description

JOB SUMMARY: 

This position is responsible for ensuring company products’ compliance to testing and characteristics standards. The position will review requirements, identify, and lead improvement or remediation projects as necessary to maintain compliance to applicable requirements including but not limited to CAPAS, Certification Audit responses, and standard or regulatory gap assessments.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: 

• Manage and support the creation of documentation to maintain product and quality system compliance to recognized standards in conjunction with product engineers.
• Manage and update the compliance target lists for NWM medical devices and quality system; lead gap assessments for changes/revisions of product compliance targets as required; perform remediation assessments and outline remediation requirements.
• Work with Engineering and Design Assurance to determine applicable standards to product lines and identify and document validation or other activities required to ensure compliance.
• Manage the review/revision of product documentation to ensure continued compliance with regulatory targets.
• Lead and support process or procedure improvement projects as required to ensure continued QMS compliance.
• Support third party and regulatory compliance Audits (MDSAP, ISO 13485, MDR, etc)
• Responsible for continued compliance of the QMS to regulatory requirements/compliance targets
• Must maintain all training requirements to the position, while seeking out opportunities for growth and continuous development
• Represent QMS QA in cross functional meetings.
• Adhere to and identify opportunities to improve the QMS and its processes.
• Stay current with organizational and industry information and routinely mentor/lead other members of the organization on new or revised compliance practices.
• Provide compliance subject matter expertise during audits, inspections, and inquires. 

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to work in and lead a team and independently
• Excellent organizational and communication skills
• Great attention to detail
• Problem solving and creativity.
• Ability to interpret, understand and communicate regulatory requirements as applicable.
• Capable of training others on quality system and regulatory requirements, concepts, and quality procedures
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Proficient in Microsoft Word/Excel/Outlook/PowerPoint/Visio, including statistical/data analysis and report writing skills.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in a timely manner.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree Preferably in Engineering, Technical Field, Life Science or closely related discipline or an equivalent combination of education and work experience. 
• Minimum 8 years in Quality or related field experience
• Experience in standard review and product testing in accordance with standard requirements highly preferred.

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time, including sitting at a desk and working on a computer.
• Occasionally move about inside the office and travel to and from office buildings. This may include, but is not limited to, bending and walking.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Occasionally lift up to 15 pounds. This may be done with reasonable accommodation.
• View and type on computer screens for long periods of time.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.