Systems Design Quality Engineer

Philips • Cambridge, MA

7d • $71,000 - $112,896 • Onsite

About The Position

The Systems Design Quality Engineer supports the design control process, from validating design inputs to supporting verification, validation, and design transfer, ensuring compliance with regulatory and quality standards. Your role: Review and refine quality engineering documents, initiates quality improvement projects, and provides support in risk management. Resolve quality issues, utilizes post-market analytics for continuous improvement, and prepares for quality audits to maintain adherence to internal and external standards. Ensures that appropriate quality, reliability‐and Post Market Surveillance (PMS) plans are made and include all stages of the product life cycle Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone. Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs. Provides effective oversight of the execution of the quality, reliability, PMS Plans, any Risk Management activities, and all of design related activities during the product/system lifecycle. Performs technical assessment on product quality performance and post‐market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and initiates field actions when required. Supports stakeholders during the execution of quality system‐and product audits and inspections. Provide quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.

Requirements

• You have a minimum of 1+ years' experience working in FDA regulated medical devices environments, with a focus on design quality/control and risk management (ISO 14971).
• You have experience producing and completing quality engineering documents, performing timely detailed quality engineering tasks including assessing product designs and reviewing test/performance data, and analyzing market feedback.
• You have experience completing or assisting with root cause analysis/quality problem solving and your skills include a basic understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820)
• You’re able to interact with supervisors and/or functional peer groups, with the ability to gain cooperation of others, conducting presentations of technical information concerning projects and schedules.
• You have a minimum of a Bachelor’s Degree (Required) in Engineering, Quality or related disciplines.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

• ASQ certifications desired

Responsibilities

• Review and refine quality engineering documents
• Initiates quality improvement projects
• Provides support in risk management
• Resolve quality issues
• Utilizes post-market analytics for continuous improvement
• Prepares for quality audits to maintain adherence to internal and external standards
• Ensures that appropriate quality, reliability‐and Post Market Surveillance (PMS) plans are made and include all stages of the product life cycle
• Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone
• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the quality, reliability, PMS Plans, any Risk Management activities, and all of design related activities during the product/system lifecycle
• Performs technical assessment on product quality performance and post‐market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and initiates field actions when required
• Supports stakeholders during the execution of quality system‐and product audits and inspections
• Provide quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees