Sr Quality Engineer
|Job Id: 21640|
|Job Type: Permanent|
|Industry: MEDICAL DEVICES|
|Location: Lowell, MA 01850|
The Senior Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality engineering support to the new product development process, operations/production, and quality systems. This individual will also serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.
- Provide Quality Engineering support for engineering product development, or sustained manufacturing.
- Provide Quality Project Management support as needed for product transfers from development to validation to production.
- Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination
- Develop and maintain Standard Operating Procedures.
- Develop and maintain project Quality Plans for assigned projects
- Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement.
- Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
- Provide Quality Engineering support for engineering/manufacturing.
- CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures
- Interact with customers and suppliers to resolve CAPA and complaint investigations.
- Provide Quality Support for the disposition of material via NCRs.
- Support supplier quality activities including vendor approval and maintaining and assessing vendor performance data (i.e. SCAR/on time).
- Review and document procedure changes for quality requirements and compliance with the quality system.
- Develop quality systems and procedures as needed.
- Audit support for third party audits, customer audits and internal audits.
- Support the implementation of continuous improvement initiatives.
- Develop and maintain production quality control plans.
- Initiate and maintain SPC (Statistical Process Control) for production processes
- Lead or support FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable
- May serve as backup to Quality Manager
- Complies with company, quality and safety standards, policies, and procedures
- Other duties as assigned.
- Bachelor of Science, preferably in an engineering discipline.
- Minimum experience in medical/manufacturing environment: 5years.
- Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
- Must possess excellent verbal communication, organizational and management skills.
- Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access. Minitab experience desirable.
- Must be able to read, write and speak fluent English
- Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement
- Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures; and Supports Innovation.