Summary:

The Quality Systems Specialist II is tasked with implementing Quality System requirements for designated processes, encompassing Change Control, Post Market Quality, Nonconforming Material Handling, CAR/CAPA, Equipment/Gage Calibration & Preventive Maintenance, Environmental Controls, Record Management, Audits (Internal and 3rd Party), Graphics/Labeling, Job Closing, and Production Support. This role operates with autonomy under the guidance of the Quality Systems Manager, demonstrating proficiency in specific processes and providing leadership and mentoring within the Quality Group. Responsibilities also include contributing to process enhancements, exercising sound decision-making, and exhibiting effective time and project management skills.

Duties/Responsibilities:

Graphics and Labeling: Review, redline, and create label content adhering to customer requirements and company policies. Oversee label control and reconciliation, ensuring accurate documentation of label application and scrap.
Change Control and Records: Support Speed to Market and Production teams by implementing product changes. Update job jackets, MOM, and other documents accordingly.
Nonconforming Material: Review and evaluate reported material non-conformances, ensuring appropriate segregation, disposition, and corrective actions.
Post Market: Investigate customer returns, complaints, and requests for support regarding product conformance. Implement necessary disposition and corrective actions promptly.
CAR/CAPA: Review and investigate CARs/CAPAs as requested or assigned.
Internal Audits: Conduct compliance and requirement audits of Quality System processes, manufacturing areas, and documentation. Present findings to management.
External Audits: Assist the Quality System Manager in managing external audits from customers and regulatory bodies.
Equipment and Gage Control: Manage equipment/gage calibration resources or coordinate external calibration. Ensure proper control of records and calibration labels according to procedure.
Production Support: Assist in controlling equipment preventive maintenance and work standards. Collaborate with the organization to establish work standards and support continual improvement initiatives.
Monitoring: Conduct or facilitate air, water, and surface monitoring for viable and particulate counts. Coordinate cleanroom and HEPA testing with external suppliers.

Training/Education/Experience Requirements:

High school diploma required.
Minimum 2 years of experience in a production environment.
Familiarity with quality management systems (e.g., 21CFR820, ISO 9001/13485), particularly in handling nonconforming products.
Proficiency in Microsoft Office software, especially Excel and Word. Ability to learn Quality Software Systems like Epicor and Master Control.

Preferred Qualifications:

BA/BS in Life Science or related field preferred.
Knowledge of complaint handling, root-cause investigation, and product change control desirable.
Familiarity with FDA Quality System Regulation (QSR), ISO 13485:2016, and associated standards.
Up to 5+ years of experience in a regulated industry, such as medical devices or aerospace, preferred.

Benefits:

Full-time team members become eligible for benefits starting the first day of the month following 30 days of employment. These include:

Health Insurance:
High Deductible Health Plan (HDHP) with Health Savings Account (HSA) - with an employer contribution of $1,040 annually.
High Preferred Provider Organization (PPO)
Low Preferred Provider Organization (PPO)
Flexible Spending Account (FSA)
Dental Insurance
Vision Insurance
Basic Life Insurance (Employer-paid)
Supplemental Life Insurance
Short-term Disability Insurance (Employer-paid)
Long-term Disability Insurance
401(k) Plan with a 4% Employer Match
Paid Time Off (accrued at 120 hours per year)*
9 Paid Holidays
Access to Continuing Education and Seminar Programs
Employee Assistance Program (EAP)
Fitness Room Access