Job Description
Job Overview:
JOB SUMMARY
The Quality Specialist is responsible for supporting and maintaining the Quality Management System (QMS) for medical device, pharma and combination device sterilization operations. This role is responsible for managing the change control process, creating and updating standard operating procedures, managing the training, approved supplier list and incoming inspection processes while maintaining regulatory compliance. The Quality Specialist collaborates with Quality, Operations, Validation, R&D and Engineering to ensure project work meets the applicable regulatory standards, customer specifications and applicable FDA regulations (QMSR, CFR 210 and CFR 211, ISO 13485 and ISO 14971).
This position requires deep expertise in quality engineering within a GMP environment and the ability to independently evaluate complex situations to drive effective problem-solving. The Quality Specialist is expected to demonstrate strong professionalism, communication skills and the ability to manage multiple priorities in a fast-paced environment. A Certified Quality Engineer (CQE) credential or equivalent qualification is required. The role demands reliability, a strong work ethic and a positive, collaborative approach while maintaining ownership.
PRIMARY FUNCTIONS
- Manage the change control process including creating the ECO documentation, SOP redlines, SOP updates, SOP creation and approval.
- Manage the company wide training program.
- Certify and recertify the employees with the company quality policies and procedures.
- Manage the approved supplier list and company distribution.
- Manage the incoming inspection process.
- Achieve established productivity and quality performance goals while supporting operational excellence.
- Adhere to all safety rules, quality standards, and company policies and procedures.
- Perform all assigned tasks in a safe, efficient and productive manner.
- Execute additional responsibilities, as assigned to support departmental and organizational objectives.
KNOWLEDGE, SKILLS & QUALIFICATIONS
- Bachelor's degree in engineering or related scientific discipline or equivalent experience.
- 3–7 years of Quality experience in a GMP regulated industry, preferably contract sterilization.
- Extensive working knowledge of cGMP, QMSR, ISO 13485 and ISO 14971 requirements.
- Certified Quality Engineer (CQE) credential or equivalent qualification required.
- High level of professionalism with excellent interpersonal and customer service skills.
- Exceptional time management abilities with proven success managing multiple priorities simultaneously.
- Outstanding verbal and written communication skills.
- Demonstrated ability to take ownership and drive tasks to completion.
- Demonstrated ability to work independently, collaborate effectively in a team, and drive projects to completion.
- Ability to work in a fast-paced environment with the flexibility to adjust to and adapt to shifting priorities.
- Strong analytical and problem-solving skills with sound decision making capabilities.
- Dependable, punctual and committed to maintain a positive attitude and strong work ethic.
- Must be authorized to work in the United States.
ESSENTIAL FUNCTIONS/PHYSICAL REQUIREMENTS
- Must be able to lift and move up to 40lbs.
- Frequently required to stand, walk, sit, use hands to handle and feel, use arms to reach, climb, balance, stoop, kneel, crouch, crawl, talk and hear.
- Full range of motion for wrist, hand and finger dexterity
- Distance vision/peripheral vision, depth perception, and ability to adjust focus.
- Must be able to operate a computer and other office machinery such as a copy machine and printer.
EOE/AA/M/F/Veteran/Disability
