Quality Engineer-Products and Systems

Philips; Hartford; On-site; GBP 97,000 - 156,000; Full time

Job summary

A leading health technology company in the United Kingdom is seeking a Quality Engineer to ensure compliance and quality of Sleep & Respiratory Care products. You will oversee quality plans, conduct audits, and perform assessments throughout product lifecycle. Ideal candidates have at least 3 years of experience in FDA regulated environments and a Bachelor's degree in Engineering or Quality. This is an office-based role requiring presence at company facilities.

Benefits

Generous PTO

401k with up to 7% match

HSA with company contribution

Stock purchase plan

Education reimbursement

Qualifications

• Minimum of 3+ years' experience of Quality Engineering in FDA regulated environments.
• Ability to produce quality engineering documents independently.
• Good understanding of Quality System Regulations.

Responsibilities

• Ensure Quality and PMS plans cover all product life cycle stages.
• Provide oversight on design quality activities.
• Support stakeholders during audits and inspections.

Skills

Quality Engineering

Design Quality/Control

Risk Management

ISO 9001 Knowledge

ISO 13485 Knowledge

Education

Bachelor's Degree in Engineering or Quality

Job description

The Quality Engineer-Products and Systems is a key member of our Sleep & Respiratory Care, Quality organization, accountable for ensuring our Sleep & Respiratory Care products are safe and compliant with Internal/External regulations, requirements and standards.

Your role:

• 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 ensures 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 independent 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.

Qualifications

• You have a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design Quality/Control, working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards.
• You have experience independently producing and completing quality engineering documents, performing timely quality engineering tasks including assessing quality plans, assessing product designs and reviewing test and other performance data, analyzing market feedback, and leading root cause analysis and quality problem solving.
• Your skills include a good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements.
• You have a minimum of a Bachelor's Degree (Required) in Engineering, Quality or related disciplines. ASQ certifications-Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and/or DfSS Green Belt/Black Belt preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this.

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role.

About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Philips Transparency Details: The pay range for this position in Cambridge, MA is $97,440 to $155,904. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. 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. Details about our benefits can be found.