Quality Specialist I (Inspection Coordinator)

Job Overview

The primary purpose of this position is the Quality Specialist (Inspection) will provide quality support of day-to-day Quality operations of all elements related to quality inspection within the Healthmark Quality Management System (QMS).

Job Responsibilities and Essential Duties:

• Perform all Quality functions in compliance with Quality Management System (QMS) according to 21CFR820, ISO 9001:2015, and ISO 13485:2016.
• Conduct internal audits of facility to ensure compliance with regulatory requirements under the guidance of the Head of Quality Systems and Compliance.
• Train new Quality employees and facilitate the on-boarding process.
• Participate in third party audits (FDA, ISO, other notified bodies) of the Quality System and assist with providing responses to any observations made during those audits.
• Assist management with ongoing Quality improvement initiatives. Track or trend Quality System metrics.
• Determine source of Quality problems, make recommendations for improvements, and assist with corrective and preventative actions.
• Lead inspection establishments. Lead establishment of inspections within the ERP tool from approved inspection plans.
• Assists in quality documentation as related to New Equipment Request and changes
• May assist in equipment qualification and validation
• Assist in monthly presentation and defect trending of product quality performance to management as related to inspection
• May be required to perform other duties as assigned or as needed.

Required Knowledge, Skills and Abilities:

• Communicating both orally and written with members of the organization, as well as external parties relating to Quality issues.
• Organizing and prioritizing daily duties.
• Must be a team player and able to work well with teams representing all areas of the organization.
• Problem solving and decision making – identifies and solves problem(s), acts decisively, and shows good judgement.
• Maintain appropriate focus on short-term and long-term goals.

Minimum Requirements: 

• Requires a Bachelor’s degree with 3+ years of experience in Quality within FDA regulated environment.

OR

• Requires a Master’s degree in Quality or any closely related field with 1+ year of experience in Quality within FDA regulated environment.

OR

• An equivalent combination of education and experience sufficient to successfully perform the essential duties.
• Strong knowledge of medical device regulatory requirements, including FDA 21CFR 820, ISO 9001:2015, ISO 13485:2016, etc. Medical device experience highly preferred.
• Audit training preferred.
• Fundamentals of technical writing.
• Stay abreast of current applicable Quality and Regulatory standards, guidance documents and industry working groups.

Environmental/Safety/Physical Work Conditions: 

• Standing and or sitting for long periods of time.

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.