Quality Systems Specialist (Manufacturing)
Essential Responsibilities
This position is responsible for contributing to the development, implementation, and execution of the full product lifecycle quality management program at Erbe. As a full-lifecycle quality engineer, your job duties include creation and collaboration on design and process risk management, measurement systems analysis, design verification and validation, supplier qualification, process validation, non-conformance and CAPA, and post-market surveillance. This position is also responsible for executing to both departmental and organizational goals.
- Interfaces with vendors (including Erbe GmbH) and in-house personnel on development of products.
- Develops, revises, and/or reviews product specifications regarding manufactured products (including packaging, labeling, sterilizing, biological testing, etc.) involved with Erbe USA.
- Conduct Risk Management and FMEA activities, ensuring risks are identified, evaluated, mitigated, and documented per ISO 14971 and related standards.
- Leads or supports supplier qualification and outsourced process validation.
- Leads or supports occasional supplier audits.
- Develops, revises, and/or reviews measurement systems analysis.
- Leads or supports post-market surveillance activities.
- Supports the development of regulatory submissions.
- Collaborate cross-functionally with Engineering, Manufacturing, materials management, and other functional groups to ensure product transfer, regulatory compliance, and quality integration.
- Support Process/Product Monitoring and Validation, including IQ/OQ/PQ protocols, statistical process control (SPC), process capability assessments, and process validation.
- Troubleshoots product non-conformances/failures to determine root causes and provides recommendations for corrective/preventive measures (Includes identifying, documenting, and recommending solutions to the quality problem.).
- Identifies preventive actions to minimize/eliminate potential non-conformances or problems. Verifies implementation and effectiveness of solutions to quality related issues.
- Creates, revises, and implements quality procedures (i.e., inspection/testing documentation, work instructions, etc.).
- Performs and documents training.
Supervisory Responsibility
This position is an individual contributor and has no direct supervisory responsibility.
Work Environment
This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
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. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.
Position Type and Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 7:30 a.m. to 4 p.m. Occasional evening and weekend work may be required as job duties demand.
Travel
This position may require occasional travel, with limited international travel included.
Required Education and Experience
- Bachelor's degree in biology, biomedical technology, chemistry, electronics or engineering.
- 2 + years' experience in medical device quality management; strong preference for experience with disposable instrumentation.
- ASQ Certified Quality Engineer preferred.
Position Requirements
- Thorough understanding of full lifecycle quality engineering skillset.
- Excellent verbal and written communications required; strong facilitation and interpersonal skills required.
- Must be able to communicate complex information to all levels within the organization.
- Demonstrated high quality computer skills including MS Office (particularly Excel), Outlook and some exposure to electronic quality systems.
- Must be highly detail-oriented and produce high quality work in a high-volume environment.
- Must be able to work independently using experience and judgment to make sound decisions.
Competencies
- Problem Solving/Analysis.
- Results Driven.
- Detail Orientation.
- Customer Focus.
- Technical Capacity.
- Communication Proficiency.
Additional Eligibility Qualifications
None required for this position.
Work Authorization/Security Clearance
Employees must be legally authorized to work in the United States. Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government.
AAP/EEO Statement
Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service, or other non-merit-based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
At-Will Employment
This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment-at-will rights at any time.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
