12 month + contract position
Education and Experience. BS degree in Life Sciences, Engineering (Biology, Chemistry, Microbiology, Electrical, Mechanical, Software/Computer Science) and some experience in Pharmaceutical/Biotechnology Industry required. . Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, CQM- Certified Quality Manager, etc.). . SAP, Trackwise, Lotus Notes experience preferred.
Certification* (ASQ Certified Quality Auditor (CQA) or equivalent)) preferred
The Quality Engineer will be responsible for working closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement, Marketing) and ensuring the quality of the product and processes for the assigned product line(s) are in compliance with standard Quality practices. The QE will develop, modify, apply and maintain quality standards and protocols and may also be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements. Responsible for developing, documenting and/or maintaining design history files.
Acts as the main point of contact for customer complaints. Resolves moderate to complex customer complaints and works with the Associate Quality Manager (Supervisor) on critical and sensitive issues/customer complaints. Review, evaluate, investigate, analyze and resolve complaints and problems concerning Customers, through close coordination with Operations, Quality, Complaint Group, Marketing & Sales and, by obtaining understanding of customer product expectations and functional needs to represent the customer in-plant decisions. Manages the complaint process at the plant level from start to end.
1. Develops solutions to routine problems of limited scope.
2. Follows company procedures for areas of assigned responsibility.
3. Limited knowledge of applicable regulatory, Corporate and/or Unit requirements
4. Effective communicator; ensuring all complaints are acknowledged, investigated and completed in a timely manner.
5. Conducts evaluation of customer complaints; including documentation review, sample testing, and technical evaluation of product defects.
6. Manages the resolution of customer complaints, within given time frames; identifying the problem, defining containment actions, investigating root cause, establishing corrective and preventive plans in order to eliminate or minimize the failures identified.
7. Works closely with Operations and Quality to identify potential root causes and develop and implement appropriate corrective and preventive actions.
8. Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices, which will result in product/process improvements, long-term solutions.
9. Tracks effectiveness of corrective action plans and compliance improvement initiatives.
10. Generates Situation Analysis Reports as needed, directed by the Associate Quality Manager (Supervisor), Quality Manager and other Directors in the Organization.
11. Analyzes data and identifies trends in order to develop innovative solutions; using statistical techniques to identify significant changes and proactively initiates plans/projects to mitigate the risk. Generates weekly, monthly and quarterly reports and others as needed.
12. Provides feedback pertaining to the groups involved in the complaint process.
13. Maintains complaint files according to established polices/procedures.
14. Supports company goals and objectives, polices, and procedures to maintain compliance with ISO 13485, FDA QSR and CE mark compliance.
15. Maintain a professional working relationship with internal and external customer and support staff.