Sr. Quality Compliance Specialist (Hybrid) - Merrimack, NH

Job Overview

Perform activities on behalf of the Compliance function to meet various requirements of the Quality Management System. Manage the logistical aspects of external audits.

HYBRID: This position is eligible to work from home 1 - 2 days/week.

Job Responsibilities and Essential Duties

• Execute tasks and projects that impact the Quality management System (60%):
  
  
  
  • Creation, review, and approval of Engineering Change Orders (ECOs).
  • Maintenance of Quality Management System procedures.
  • Verification of implementation and effectivity of corrective actions.
  • Improve and maintain the quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System (QMS).
  • Perform analysis on a new or revised standard and execute deliverables to support continuous compliance to applicable current standards and regulations.
  • Other duties and projects as assigned.
  
  
  
  
• Support the Management Review process and Quality/Compliance metrics reporting (20%):
  
  
  
  • Create and compile the site Management Review presentation .
  • Compile metrics and information for the Monthly Quality Meetings.
  • Document, track and drive the completion of open actions from meetings.
  • Prepare and maintain accurate documentation to support compliance activities and retain quality system records as required.
  
  
  
  
• Manage all aspects of 3rd party audits(20%):
  
  
  
  • Coordination of support staff and all logistics.
  • Assist with readiness activities for regulatory inspections and customer audits, and provide support and documentation in advance of, and during audits.
  • Cross train into all areas of back-room support.
  • Document pre- and post-audit activities.
  
  
  
  

Minimum Requirements

• Bachelor's Degree in Engineering, Quality or related technical field, or equivalent experience.
• 5-7+ years' experience in highly regulated industry (medical device, automotive, electronics, etc.).
• ASQ certifications considered a plus.
• Internal auditing experience and qualifications considered a plus.

Required Knowledge, Skills and Abilities

• Exposure to audits, including preparation, execution, and documentation.
• High level of attention to detail and accuracy.
• Good analytical and problem-solving skills with the ability to identify root causes and propose solutions.
• Strong computer skills, including MS Office applications (Word/Excel) are required.
• Excellent written and verbal communication skills; professional interpersonal skills, with the ability to work collaboratively across teams.
• Demonstrated time management and organizational skills; ability to work independently and as part of a team. Project management skills considered a plus.

Supervision/Management Of Others:

• No direct reports.

Internal and External Contacts/Relationships

• Works with various internal functional areas.
• Interaction with representatives from regulatory agencies.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and other related office accessories/devices to complete assignments.
• Hybrid (office/remote) environment; 2-3 days onsite weekly; more often during audits.
• May work extended hours during peak business cycles.

Salary Range: $95K - $120K Depending on Experience

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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