Senior Quality Engineer at The GN Group

Job Description

Senior Quality Engineer at The GN Group

Essential Functions (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Manage improvement projects within Operations department

• Propose and implement improvements utilizing the CAPA and NC systems

• Support all departments to ensure compliance with the QMS and lead continuous improvement efforts of the QMS

• Provide support to all quality activities (i.e. CAPA, NC, Complaint, Change Control, Validation, etc.) via risk-based approach

• Support/Lead QMS audits (internal and external)

• Participant in Management Review (meeting and preparation)

• Work with Corporate Quality on projects

• Ensure alignment between local and corporate procedures

• Monitor quality objective status

• May assign tasks to and direct quality engineers and other quality staff

• May plan and coordinate detailed aspects of work within the quality department

• Other responsibilities as required

Competencies (Knowledge and Skills needed for this position.)

• Strong communication skills, written and verbal

• Problem solving skills and utilization of tools

• Solid understanding of ISO 13485 and 21 CFR 820

• Detail oriented

• Leadership skills

Desired Qualifications

Required Education:

BS Engineering and/or equivalent work experience

Experience:

2-5+ years of experience in quality engineering, quality control, quality improvement projects, root cause analysis, CAPA and/or relevant roles. 3+ years of medical device manufacturing and/or experience with 13485 preferred Certified Lead Auditor certification highly preferred (ISO 13485:2016 or ISO 9001:2015) Experience with Notified Body Audits highly preferred

Travel: as necessary (less than 5%)

Other:

Other Information

Direct reports:

n/a

Indirect reports:

n/a

Working Environment:

Open office environment, located near a manufacturing facility

Physical Demands:

Sitting, standing, lifting (no more than 40 lbs)

Position Type and Expected Hours of Work:

Full time position. Working Monday through Friday, with potential overtime and weekend support if necessary

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.