R4269 Senior/Principal Quality Systems Consultant (Open)

Job Description

Principal Duties and Responsibilities

Quality Systems Consultant & Senior Quality Systems Consultant

Participate in meetings with prospective clients.
Provide the scope of the project and relevant information to support the creation of proposals.
Identify opportunities to bring in new projects/clients.
Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.

Principal Quality Systems Consultant

In addition to the items listed above:

Speak at conferences, webinars, or other marketing venues.
Role-Specific Duties and Responsibilities
Demonstrated knowledge of ISO 13485, Good Manufacturing Practices (FDA QSR), EU Medical Device Directives
Perform QS gap analysis and write clear concise report
Assist clients in addressing QS gaps, including CAPA, complaints, Design Controls, Risk Management, Document Controls, etc.
Lead auditor for client and supplier audits; pre-ISO, ISO 13485, ISO 9001, mock QSR inspection
Assist clients with ISO audits and FDA inspections
Develop and implement Manufacturing Process and Equipment Validations
Manage at least 3 client projects concurrently
Develop estimates for audits and gap analyses
Implement a Document and Data control system, both virtual and on-site
Support client on-site with Quality Engineering/Quality Management
Evaluate and interpret standards related to the product, quality system/design control, and manufacturing for the client; perform a standard evaluation
Auditor Certification is preferred, e.g. ASQ CQA or ASQ CBA

Senior Quality Systems Consultant

In addition to the items listed above:
Plan and implement full ISO 13485/QSR Quality Systems as well as systems for small and virtual companies
Identify the level of QSR implementation a project/client requires by understanding the practical implications of size and complexity
Act as a Quality Systems expert during ISO audits and FDA inspections
Develop estimates for process/equipment validations, design history files, tech files, and QS implementation

Principal Quality Systems Consultant

In addition to the items listed above:

Act as a lead during ISO audits and FDA inspections
Defend corporate quality rationale to an auditor or regulatory agency personnel (i.e., 483 finding(s) for Device/Biologic and/or Combination Products
Develop and implement strategies to assist clients with major audit deficiencies, including the development of FDA 483 responses
Act as a Quality System Manager/Director on-site at a client

Qualifications and Skills

Qualifications
Quality Systems Consultant

Requires a minimum of

Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience; and
Project management experience.
Fluency in English and local language, if different, required.

Senior Quality Systems Consultant

Requires a minimum of

Bachelor’s degree or equivalent experience in a related field, with a minimum of 8 years of relevant experience; and
Project management experience.
Fluency in English and local language, if different, required.

Principal Quality Systems Consultant

Requires a minimum of

Bachelor’s degree or equivalent experience in a related field, with a minimum of 10 years of relevant experience; and
Project management experience.
Fluency in English and local language, if different, required.

Senior Principal Quality Systems Consultant

Requires a minimum of

Bachelor’s degree or equivalent experience in a related field, with a minimum of 12 years of relevant experience; and
Project management experience.
Fluency in English and local language, if different, required.

Technical Competencies

Knowledge and experience with Quality System standards and regulations.
Ability to assess/audit compliance of Quality Systems to applicable standards and regulations.
Ability to develop Quality Systems that are compliant with applicable standards and regulations.

Working Conditions

The physical demands described here are 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.
While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
Extensive use of a computer keyboard.