Quality Specialist (Medical Device)
The Quality Specialist is responsible for oversight of the First Article Inspection process (FAI), creating and/or reviewing control plans for product and materials, the calibration program, creation, review and approval of inspection instructions, and aiding in quality control inspections when necessary. The individual will also assist in nonconforming material containment, investigation and resolution and Corrective and Preventive Action (CAPA) investigations, implementation of actions and verification of effectiveness.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Collaborates with cross-functional teams to investigate issues
- Actively participates in process improvement initiatives, taking cross-functional and standardized work into consideration to improve productivity.
- Oversees calibration program, ensuring all equipment is identified whether it requires calibration and equipment requiring calibration is calibrated and maintained.
- Evaluates nonconforming materials to determine root causes and to implement appropriate corrections, dispositions and determination whether CAPAs are required.
- Assists in investigating, determining root cause, planning and taking actions for CAPAs and reviewing and ensuring effectiveness of CAPAs.
- Maintains a working knowledge of all systems, procedures, and products pertaining to the work area
- Participates in cross functional quality teams
- Administration of clean room certification and pest control programs
EDUCATION & EXPERIENCE REQUIREMENTS
- 2-year post-secondary education in a technical or quality-related program or 7+ years of Quality work experience in a highly regulated environment (medical device, biotech, etc.).
- 5+ years of work experience in highly regulated environment
- Related experience in a medical device environment
- Hands on utilizing measurement devices (micrometers, caliper, force and pull gages, etc.)
- Previous experience with calibration system management, nonconformance investigation and CAPA
SKILLS & ABILITIES
- Overall knowledge of quality control fundamentals, reliability concepts, statistical quality control and basic root cause analysis concepts
- Expertise in reading and comprehending drawings and schematics
- Knowledge of ERP systems (IFS) or equivalent
- Knowledge of GD&T
- Good understanding of the FDA GMP & ISO 13485 requirements
- Basic knowledge of risk management
- Good communication skills
- Must be detail oriented and possess strong organizational skills with the ability to prioritize
- Strong computer skills in Microsoft Office (Word and Excel)
WORKING CONDITIONS & PHYSICAL DEMANDS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.
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