Quality Engineer II

Essential Responsibilities

• Creates revises and implements quality standards as well as procedures i.e. Standard Operating Procedures (SOPs) accordance with established Erbe Quality system.
• Implement and evaluate changes to existing processes designed to improve product quality productivity and overall equipment efficiency.
• Develop and maintain process documentation ensuring that processes and procedures are clearly stated and understandable for all employees.
• Provide technical support/solutions to manufacturing processes improve yield and throughput drive cost reduction activities and improve on part quality.
• Demonstrated ability to start-up operate and shut down process related equipment. Must be able to work independently on new process development as well as troubleshooting current production issues.
• Monitor and report issues with tooling make recommendations for refurbishment based on production factors such as cycles process capability and tooling history.
• Interact with stakeholders to resolve issues and provide project updates.
• Implement technical solutions including statistical methodology to meet cost quality and delivery expectations.
• External and internal Supplier Quality experience.
• Author validation documents and records including IQ OQ and PQ reports and protocols.
• Drive Design Control Processes including Verification and Validation Activities
• Test Method Development
• Conduct Risk Management and FMEA activities ensuring risks are identified evaluated mitigated and documented per ISOâ14971 and related standards
• Work with Design files including drawings specifications and records.
• Collaborate cross-functionally with Engineering Manufacturing materials management and other functional groups to ensure product transfer regulatory compliance and quality integration
• Evaluates and establishes controls for all suppliers/vendors who have an impact on product quality; conducts initial assessments as well as yearly performance reviews to convey and resolve quality issues as they arise.
• Reviews testing methodologies equipment documentation etc. for appropriateness to demonstrate that conformance to established standards and/or specifications.
• Reviews product and system failures to determine root causes with recommendations for corrective/preventive measures. Identifies preventive actions to minimize/eliminate potential problems. Verifies implementation and effectiveness of solutions to quality related issues.
• All other duties as assigned by the Quality Manager.

Supervisory Responsibility

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

Work Environment

This position operates in an 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 machinery on the manufacturing floor and numerous devices that are sold by the company.

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 and stoop; use hands to finger handle or feel; and reach with hands and arms. The employee frequently is required to lift and/or carry up to 20 pounds. For more information please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.

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 requires no measurable travel.

Required Education and Experience

• Bachelors degree in engineering science or related area of study required.
• 3-5 years experience in the medical industry experience in quality control and quality assurance in a Manufacturing setting particular working with Injection Molding and ancillary processes (i.e. bonding printing joining laser welding assembly packaging)
• Competence in applying and assuring compliance to QSR and EU Requirements as well as applicable current International Standards desired
• Working knowledge of medical device sterilization processes (e.g. EO) including validation support routine monitoring and sterilization-related investigations is preferred.
• Diverse technical background in injection molding processing tooling equipment materials manufacturing and quality including validations (IQ OQ PQ).
• Knowledge of applicable regulatory standards is required
• Lean Six Sigma Green Belt and experience is preferred
• ASQ Certification is preferred
• Familiarity FDA QSR cGMP ISO CE and EU-MDR/MDD rules and regulations

Position Requirements

• Excellent verbal and written communications required; strong facilitation and interpersonal skills required.
• Thorough understanding of research and development validations quality and regulatory are necessary with operations and quality systems auditing capabilities
• Must be able to communicate complex information to all levels within the organization.
• Demonstrated high quality computer skills including MS Office and some exposure to electronic quality systems.
• Must be detail-oriented and produce high quality work in a high-volume environment.
• Must be able to handle confidential information in an appropriate and professional manner.

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 position 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:

IC