Job Description

JOB PURPOSE

• Partners with the Post-Production Support group to provide Quality Assurance Compliance oversight for post-production risk reviews.
• Review and analyzes post-market data to identify signals that could impact risk or design for Alcon products.

JOB FUNCTIONS
Essential Functions
Duties are listed in order of greatest importance. Other responsibilities may be assigned.
1. Works closely with the Fort Worth R&D QA team and stake holders both on-shore and off-shore to coordinate QA oversight of Post Production Risk Review process and ensures the reviews and associated deliverables are completed per Alcon\xe2\x80\x99s procedures.
2. Review and analyzes post-market data to identify signals that could impact risk or design for Alcon products.
3. Identifies areas of improvement for the Post Production Risk Reviews and facilitates the implementation of new processes.
4. Supports audits, regulatory, and other compliance activities by querying, analyzing, and providing requested information and supporting documentation as required for changes in regulatory requirements.
5. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
6. Sustain reporting and trending of metrics associated with the Quality System at R&D design and development center.

QUALIFICATIONS
Minimum Requirement
1. BS of Engineering with 5 year experience; or MS with 3 yrs. experience; 2 year experience in the Medical Device industry
2. Engineering generalist with demonstrated interest in multiple engineering and scientific fields.
3. Demonstrated ability to work independently, proactively identify issues, recommend, and implement solutions, and deliver quality results on schedule while managing multiple tasks and customers.
4. Knowledge of ISO 14971 and ISO 13485 (or US 21 CFR 820.30)
5. Superior interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a virtual, remote and asynchronous environment.
6. Technology savviness to automate simple tasks for process improvement and cycle time reduction (e.g., data queries, data analyses, documentation)
7. Great attention to detail and problem-solving abilities
8. Hands-on experience with Quality Management Systems (QMS) and testing methodologies

Knowledge, Skills and Abilities
Personal Effectiveness Competencies:

• Project Excellence - Fundamental
• Continuous Learning - Intermediate
• Digital and Technology Savvy - Intermediate
• Operational Excellence - Intermediate
• Breakthrough Analysis - Intermediate
• Organizational Savvy - Intermediate
• Good documentation - Fundamental

Skills and Knowledge:

• STEAM \xe2\x80\x93 Applied Science, Technology, Engineering, Arts and Math
• Understanding of FDA/ISO regulations for Medical Devices (21 CFR 820.30, ISO 13485)
• Risk Management for Medical Device (ISO 14971)
• Regulations and Guidelines
• Excellent Technical/Scientific Writing in English in a regulated environment
• Superior verbal English communication skill (in a remote environment)
• Microsoft Office suite (i.e., Word, Excel, PowerPoint, Visio)

Experiences

• Cross Functional collaboration - Primary
• New Product Innovation - Secondary
• Accountability - Primary
• Influencing without Authority - Primary
• Managing Crisis \xe2\x80\x93 Secondary
• Functional Breadth - Secondary

Licenses and Certifications
Certified Quality Engineer Preferred
Language Skills
1. Fluent English; excellent verbal and written communication skills

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Alcon