Quality Engineer II-Requisition Number 18-6174
Works within an operations team to identify and implement effective controls to support the development, qualification, and distribution of products to meet or exceed internal and external requirements
- Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
- Perform statistical analysis to determine process capability, inspection acceptance and to analyze trends. Supply quality metrics as requested.
- Maintains schedules for projects; identifies problems and recommends solutions to all project activities.
- Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as ship holds, service errors, line yields, final release, supplier performance and customer experiences to internal product improvement teams
- Handles demanding technical and analytical assignments requiring analysis, research and sensitivity as well as independent performance.
- Prepare, route and maintain department paperwork, reports and records on a timely basis.
- Support the generation of incoming and/or final inspection documents and procedures in support of product release criteria. Support to including generation of inspection methods, procedures, techniques, frequencies and documentation. Provide data and guidance to the site QSRB in the disposition and resolution of discrepant materials related to design or use issues.
- Supports in the development and maintenance of Quality Management System procedures
- Provide leadership and strategies to assure quality infrastructure and capability as the company grows
- Support audits, CAPA/NC/MRB investigations and reports
- Perform other related duties as assigned
Bachelor's degree in engineering or equivalent specialized experience with emphasis in Quality.
- 3+ years' experience within medical device / FDA regulated industry preferred.
- Manufacturing or distribution experience preferred.
- Quality certification preferred (e.g. CQE, CRE, CQM, Six Sigma, etc.).
- Working knowledge of International Quality and Regulatory requirements is preferred (FDA's 21 CFR Part 820, ISO 13485, Council Directive 93/42/EEC, MEDDEV, Canadian Medical Device Regulations, Japanese JPAL requirements
- Relevant Experience working within Medical Device, Pharmaceutical, or other FDA-regulated Industry is an advantage
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
- Strong communication skills, both oral and written with the ability to prioritize and meet deadlines for multiple projects.
- Experience with SAP applications
- Ability to work well in a fast-paced environment under pressure and maintain positive, enthusiastic attitude
- Eagerness to learn and expand responsibilities
- Ability to work effectively in a team environment and build strong working relationships.
- Experience with systematic project management and problem-solving methodologies is preferred
- Statistical analysis techniques with excellent verbal, written, and presentation skills
TRAVEL REQUIRED: up to 10%
The Quality Engineer II is primarily responsible for providing engineering and process support for the North American Distribution Center.
- Work collaboratively with cross functional teams to track data, identify improvement projects and implementation to improve Key Performance Indicators.
- Schedule and participate in activities to support and maintain compliance with applicable regulatory and Quality Management System requirements.
- Support the maintenance and development of the corrective and preventative action (CAPA) system and internal non-conformance system to support the overall facility quality management system.