Overview
Quality Engineer- Products and Systems is a key member of the Sleep & Respiratory Care, Quality organization, accountable for ensuring our Sleep & Respiratory Care products are safe and compliant with internal/external regulations, requirements and standards.
Responsibilities
* Ensure that appropriate Quality, Reliability and Post Market Surveillance (PMS) plans are created and include all stages of the product lifecycle.
* Support Quality Plan design for hardware and software, ensuring they meet quality and compliance standards for every planned milestone. Validate key design inputs such as usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
* Provide effective oversight of the execution of Quality, Reliability, PMS Plans and all design-related activities during the product/system lifecycle, including risk management activities.
* Perform independent technical assessment of product quality performance and post-market product quality analysis to lead quality-related problem solving and root cause analysis during design and manufacturing; initiate field actions when required.
* Support stakeholders during execution of quality system and product audits and inspections. Provide quality engineering support, including assisting organizational units in resolving quality engineering deficiencies.
Qualifications
* Minimum 3+ years of Quality Engineering experience in FDA-regulated, medical device environments, with a focus on Design Quality/Control, knowledge of Risk Management (ISO 14971) and global medical device regulations, requirements and standards.
* Experience independently producing and completing quality engineering documents, performing timely quality engineering tasks (assessing quality plans, product designs, reviewing test and performance data, analyzing market feedback) and leading root cause analysis and quality problem solving.
* Strong understanding of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR 803, 806 & 820) and medical device process requirements.
* Minimum Bachelor’s degree (Required) in Engineering, Quality or related disciplines. ASQ certifications (CQE, CQA) and/or Design for Six Sigma (DfSS) Green Belt/Black Belt preferred.
* Ability to meet minimum physical, cognitive and environmental job requirements with or without accommodation.
How we work together
We believe we are better together. Office-based teams are expected to work in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are typically at customers’ or suppliers’ locations. This is an office role.
About Philips
We are a health technology company. We built our company around the belief that every human matters, and we won’t stop until everybody, everywhere has access to quality healthcare that we all deserve.
Compensation and benefits
The pay range for this position in Cambridge, MA is $97,440 to $155,904. The actual base pay offered may vary based on job-related knowledge/skills, experience, business needs, location, and internal equity. Other compensation (e.g., annual incentive bonus, long-term incentives) may be offered. Philips Total Rewards includes benefits such as PTO, 401k match, HSA contribution, stock purchase plan, education reimbursement, and more. Details about benefits can be found on the Philips careers site.
Additional Information
* US work authorization is required. Sponsorship for a work visa is not available.
* Relocation benefits are not provided for this position. You must reside in or be within commuting distance to Cambridge, MA.
* This role may require travel up to 10%.
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