Quality Systems Specialist

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review and monitor deviations and nonconforming material reports using the eQMS and ensure all disposition activities and training are completed in a timely fashion.
• Ensure items and materials listed on lot history records are provided by approved vendors using accepted material. Including raw material certificates within shipping documents as required per MPI and SOP.
• Create parts within the eQMS and ensure that they are correctly linked to Suppliers, Customers, and related modules when this functionality is available.
• Assure that all quality system records including traceability records are scanned, stored, and retained as defined in SOPs Standard Operating Procedures (SOPs).
• Perform layered process and product audits and/ or Gemba walks at the direction of Quality management.
• Perform inspection, measuring, testing and data collection for critical milestone tasks. Assist Engineering, Manufacturing and Quality in support of equipment validation activities, including verification inspection/testing activities.
• Train and mentor Quality Inspectors and Technicians.
• Works semi-independently to perform operations under minimal supervision.
• Compliance to all applicable Standard Operating Procedures (SOPs) and adherence to CER gowning and personnel hygiene requirements. Ensure others in controlled environments always follow these requirements.
• Assist with Material Review Board (MRB) for nonconforming and suspect materials.
• Oversee Deviations for expiration and ensure relevant deviations are included with lot history records.
• Assist in maintaining an accurate equipment calibration and preventive maintenance program.

COMPETENCIES:

To perform this job successfully, and individual should demonstrate the following competencies:

• Interpersonal Skills – Provide clear input to engineering and operations staff on required actions.
• Oral and Written Communication – Listens and gets clarification. Writes clearly and informatively; Able to read and interpret written information.
• Teamwork – Balances team and individual responsibilities; Contributes to building a positive team spirit.
• Motivation and Planning/Organizing - Measures self against standard of excellence. Uses time efficiently.
• Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Quality – Demonstrates accuracy and thoroughness; Looks for ways to ensure a culture of compliance; Applies feedback to improve performance; Monitors own work to ensure quality.
• Safety and Security – Observes all safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Adaptability – Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes, delays, or unexpected events.
• Attendance/Punctuality – Is consistently at work on time; Arrives at meetings and appointments on time.
• Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Initiative – Asks for and offers help when needed.
• Innovation – Generates suggestions for improving work.

QUALIFICATIONS: 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 essential functions.

EDUCATION and/or EXPERIENCE: High School Diploma or two year technical degree or minimum of 5+ years’ experience in medical device industry performing quality assurance activities. Basic drawing and specification understanding.

LANGUAGE SKILLS: Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals and use Microsoft Word.

MATHEMATICAL SKILLS: Must have the ability to calculate figures and amounts using basic math (i.e. decimals, addition, subtraction, multiplication and division) and use Microsoft Excel.

REASONING ABILITY: Have the ability to apply common sense; Understanding to carry out detailed but uninvolved written or oral instructions; Must have exceptional attention to detail and organizational skills.

OTHER SKILLS and ABILITIES: Ability to use industry standard measurement, inspection and test equipment and to compare measurements to documented standards.

PHYSICAL DEMANDS: 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 sit or stand and work at a computer. The employee may lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and ability to adjust focus.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES:

This job has no supervisory responsibilities.

Compensation: The pay range for this position is $38.49–$49.00 per hour. The actual starting rate will be determined based on factors including, but not limited to, the candidate's relevant experience, qualifications, skills, education, certifications and business needs