Job Details

Requisition Number 18-0068
Post Date 2/18/2019
Title Quality Engineer
City Westborough
State MA
Description Responsibilities:

• Support the quality department in ensuring that the company’s standard operating procedures meet the necessary regulations and that they are being followed
• Be the internal Quality Strategist and act as ISO 13485 Champion to lead the implementation and development of product development processes and tools
• Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
• Articulate quality initiatives and considerations with internal and external customers and champion quality initiatives within project teams.
• Provides input and recommendations for the identification and selection of quality system improvement projects.
• Monitors quality metrics and progress toward quality system goals including nonconforming material, internal audits, CAPAs, SCARs, Document Control, Training and Calibration
• Job requires interactions with project team members as well as members of the Quality extended team
• Creation of quality documentation and development of SOPs for the facility and products in line with industry standards. Validate quality processes, write and update QA procedures, as required
• Work with engineers to determine testing and regulation standards that must be adhered to as the product is nearing commercialization
• Proactive review and improvement of systems and processes to ensure maintenance of standards
• Working closely with staff to ensure quality protocols are followed and documentation is correctly maintained and implement any new changes or adaptations based on a quality review
• Analyzing problems reported and developing improvements to overcome them
• Continuous improvement to the quality processes defined
Requirements Qualifications:
Education, background and Skill Requirements:
• Education: Master’s degree with a technical and quality background or regulatory discipline is required.
• QMS experience with ISO9001 or ISO13485 and IEC62304. Formal training in quality planning, tools and analysis
o In depth knowledge of quality principles and technical tools (problem analysis, statistical tools, control charts and other quality methodologies).
o 3-5 years’ experience in a development, manufacturing or quality environment including experience in leading cross-functional teams.
o Working knowledge of various processes required.
• Analytical skills – need to be able to spot problems quickly and find the underlying causes so changes can be made
• Critical thinking – once problems are identified, solutions and improvements must be found. This might involve thinking about a process, procedure or problem in a completely new way.
• Attention to detail – as part of a team responsible for the creation and implementation of quality systems, as well as the team who notices and reports on problems, every detail must be noticed and acted upon when necessary
• Communications skills – strong written and verbal communication skills are key. Must be able to relay potentially complex ideas to a wide range of audiences – both in personal consultations but also through company SOPs and quality documentation. Must be able to provide concise executive summaries of quality issues, changes needed or made, results delivered.
• Team working skills – working as part of the quality team, and in close coordination with other teams throughout the company (as well as potential for interaction with suppliers and customers) is a key part of quality engineering

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