Quality Specialist

Quality Department Record Reviewer

Responsible for reviewing and filing records for the Quality Department. May participate in revising documents, organizing files, and helping to design new systems. Assists in the development and maintenance of Quality Assurance systems and projects.

Essential Duties:

All duties to be performed according to the established standard and in compliance with all company policies and procedures while maintaining regular, prompt attendance and availability for overtime as needed:

• Assist and support the organization's efforts to meet regulatory requirements and ISO 9001 conformity.

• Assist in Internal Audits both as an individual and as a team member.

• Assist the team in the preparation of reports, presentations, and Quality Assurance materials.

• Assist in performing Gage R&R study

• Assist in maintaining all Supplier evaluations or assessments per the approved supplier list.

• Assist in investigating product and supplier compliance.

• Perform Document Control functions and assist all employees with questions pertaining to all aspects of that system.

• Conduct special projects as needed.

• Assist in maintaining the necessary active documentation as well as archiving of documentation as set by the facilities Quality System.

• Assist with the CAPA process and perform CAPA Verifications.

• Maintain metrics and communication board.

• Assist in auditing of batch (DHR) records and manufacturing procedures.

• Assist in writing standard operating procedures and forms related to operations.

• Assist in the maintenance of the Quality Manual.

• Assist with maintaining Master Device Records.

• Maintain document control in QT9.

• May perform Batch (DHR) Record Reviews.

• Assist in investigations of failures, non-conforming products, and deviations.

• Initiate disposition of defective products and materials.

• Regularly evaluate monitoring equipment.

• May participate in audits by regulatory agencies.

• Assist in maintaining the Master Equipment Listing.

• May perform calibration and verification of in-house production equipment.

• Assist in managing the Calibration Process: Scheduling for outside calibration.

Other Duties:

• Maintain a clean and organized work environment.

• Observe all company policies, rules, and safety practices.

Physical Demands:

The task of this position generally requires duties to be performed by:

• Occasionally lift and move up to 25 pounds to waist or shoulder height unaccompanied.

• Regularly stand/walk or sit for the duration of the shift.

• Occasionally required to stoop, climb, or balance.

Work Environment:

• Normal office environment and Factory Floor.

• Must be able to access and navigate each department in the office and factory floor.

• Regularly work with others.

• The noise level may vary in the office and the factory floor

• Exposed to hot conditions (factory floor/outside during incoming inspection).

Safety and Ergonomic Requirements:

• Must practice safe work practices at all times and report any unsafe conditions immediately.

• Follow all personal dress requirements according to the established dress code and safety requirements.

Qualification Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

• Associate degree or Bachelor's degree (B.S.) from a college or university; or one-year related experience and/or training; or equivalent combination of education and experience.

Language Skills:

• Read, analyze, and interpret technical procedures and data.

• Write reports and procedure manuals.

• Effectively present information and respond to questions from management and co-workers.

Reasoning Ability:

• Ability to multi-task and prioritize.

• Strong time management and organization skills.

• Demonstrate good judgment and decision-making skills.

Mathematical and Computer Skills:

Work with mathematical concepts such as probability and other statistical calculations.

Apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Working knowledge of internet programs and the Microsoft Office programs, including Microsoft Word, Microsoft EXCEL, and Outlook.