Design Quality Engineer
In this role you
The Electro-Mechanical Medical Device Design Quality Engineer facilitates in providing quality oversight of system, hardware, and risk management throughout the product life cycle, independent oversight of the system design input process, design of Verification and Validation (V&V) activities, and performance in the field, working under limited supervision. The role independently produces quality engineering documents, executes assessment of product and system designs, and validates key system design inputs.
Your role:
• Independently produces quality engineering documents, coordinates quality plan design for hardware/software and system design, and supports stakeholders during the execution of quality system, product audits, and inspections.
• Provides effective oversight of execution of quality, reliability, PMS Plans, Risk Management activities, and all design related activities during the product/system lifecycle including deliverables created by other functions/organizations to assure product and process compliance.
• Cultivates effective relationships, shares knowledge, provides influence over projects and peer groups, demonstrating full understanding of area of specialization, and possesses working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and ISO 9001.
• Establishes and improves Quality & Regulatory (Q&R) capabilities supporting customer services business and leads in design and deployment of customer service strategy and solutions which exceed customer expectations.
• Independently produces CAPA records and performs timely Corrective and Preventive Action (CAPA) engineering tasks, including assessment of issue descriptions and reviewing CAPA data sources.
You're the right fit if:
Bachelor's Degree required. Master's Degree preferred in Mechanical Engineering, Electronics Engineering, Science or equivalent.5+ years of experience in Design Quality Engineering, Safety Engineering, Product/Process Engineering.ASQ CQE or CQM . 13485 auditor certifications.Knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and ISO 9001.You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.How we work together
We believe that we are better together than apart. 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 healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business.Discover our rich and exciting history.Learn more about our purpose.Learn more about our commitment to diversity and inclusion.Philips Transparency Details
The pay range for this position in Latham, NY is $75,000 to $130,000, Annually.
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.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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 here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Latham NY.
#LI-PHI
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.