Sr. Quality Engineer

Essential Responsibilities

This position is responsible for contributing to the development implementation and execution of the full product lifecycle quality management program at Erbe including quality planning and execution for manufacturing readiness and production transfer. 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 post-market surveillance and cross-functional transfer of products and processes into production. 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 contract-manufactured products (including packaging labeling sterilizing biological testing etc.) involved with Erbe USA.
• Develops revises and/or reviews product and process risk management files.
• Leads or supports supplier qualification outsourced process validation and ongoing supplier controls/performance reviews.
• Leads or supports occasional supplier audits.
• Develops revises and/or reviews measurement systems analysis.
• Leads or supports manufacturing production transfer activities ensuring process readiness regulatory compliance and quality integration across Engineering Manufacturing Supplier Quality and materials management.
• Authors reviews and/or approves validation documents and records including IQ OQ and PQ protocols/reports to support manufacturing readiness and transfer to production.
• Develops and maintains process documentation to ensure manufacturing methods inspection requirements and procedures are clearly defined controlled and deployable for production.
• Provides technical quality support for manufacturing processes including evaluation of process changes to improve product quality yield throughput and overall equipment/process efficiency.
• Collaborates on test method development and reviews testing methodologies equipment and documentation to confirm conformance to established standards and specifications.
• Works with drawings specifications and manufacturing records to ensure complete and accurate transfer of product requirements into production.
• Applies statistical methods and FMEA-based risk tools to support process capability validation effectiveness and quality decision-making during product and process transfer.
• Leads or supports post-market surveillance activities.
• Supports the development of regulatory submissions.
• 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 and process documentation (i.e. inspection/testing documentation work instructions SOPs and related records).
• Performs and documents training.
• Additional duties as assigned by Manager.

Supervisory Responsibility

This position is an individual contributor and has no direct supervisory responsibility.

Work Environment

This position operates in a professional office and manufacturing environment. This role routinely uses standard office equipment such as computers phones photocopiers filing cabinets and fax machines. The position also interacts with manufacturing equipment production processes and finished devices on the manufacturing floor as needed to support validation transfer and issue resolution.

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 4:00 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

• Bachelors degree in engineering biology biomedical technology chemistry or electronics.
• 5 years experience in quality engineering with medical devices; strong preference for experience supporting manufacturing process transfer process validation and class II disposable accessories.
• Experience authoring and/or reviewing validation deliverables (including IQ OQ and PQ) test methods and process documentation to support production transfer preferred.
• Working knowledge of FDA/QMSR ISO 13485 ISO 14971 and applicable EU requirements preferred.
• ASQ Certified Quality Engineer preferred.

Position Requirements

• Thorough understanding of full lifecycle quality engineering skillset including design control risk management process validation supplier quality and manufacturing transfer.
• Demonstrated ability to lead or support cross-functional product and process transfer activities with Engineering Manufacturing materials management and suppliers.
• Strong working knowledge of drawings specifications manufacturing records test methods and statistical/risk tools (e.g. MSA FMEA and process capability) to support quality decisions.
• 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.

Required Experience:

Senior IC