Job Title
Quality Engineer
Job Description
The Quality Engineer is responsible for qualifying/ensuring Philips’ Hospital Patient Monitoring (HPM) parts, components and materials are safe, compliant and reliable, ensuring patient safety and customer satisfaction.
Your role:
- Executes timely quality engineering/assurance processes, ensures maintenance and documentation of quality assurance systems, and reviews/approves quality documentation/records, with responsibility for their generation when necessary. Executes: the organization's comprehensive quality assurance and compliance policy, cultivates internal quality awareness, introduces and enforces necessary processes and tools to ensure product excellence and customer satisfaction, standardizes quality systems across sites and sectors, and institutes an efficient Management Review process.
- Contributes to improvement initiatives and implements change within the domain, tackles diverse challenges creatively, and exhibits sound judgment in selecting methods and techniques to effectively resolve issues.
- Reviews and approves nonconforming records related to warehouse material, executes delivery hold, and supports nonconformance management processes, including root cause analysis, and corrective and preventive actions (CAPA), all conducted within specified timelines.
- Analyzes quality data for reports, validation processes, and process improvement initiatives, troubleshoots departmental issues, escalates issues to the direct manager as needed, and may generate departmental metrics and reports to management.
- Helps to verify quality assurance departmental metrics, monitors and analyze daily management board data, and generates insights from departmental metrics to report to management for informed decision making.
- Ensures the qualification and maintenance of sub-processes within supplier networks, conducts supplier quality audits, applies company excellence practices to identify and resolve major supplier quality issues, and supports continuous improvement initiatives in supplier performance and product quality.
- Conducts routine quality inspections and audits across manufacturing processes, materials, and finished products to identify deviations and non-conformities.
- Participates in initiatives aimed at establishing uniform approaches and methodologies to promote uniformity within the supply base and facilitates cohesion and efficiency across operations.
You are the right fit if:
- You have a minimum of 3+ years’ experience in FDA regulated Medical Device manufacturing/warehousing quality environments (ISO 13485), with a focus on parts qualification, quality audits/inspections, nonconformance management, control plans, QMS compliance/standardization, and continuous/process improvement.
- You have proven experience in Risk Management (ISO 14971), root cause analysis and CAPA.
- You have proven experience in data analysis- monitoring and analyze daily management board data and generate insights from departmental metrics to report out to management.
- You have a minimum of a Bachelor's Degree in an Engineering or quality discipline. Six Sigma/DfX (DfQ/DfR) knowledge and/or certifications desired.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together:
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-based 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 Lockbourne, OH is $92,000 to $146,000
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.
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.
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 Lockbourne, OH.
- May travel up to 10%
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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 including Disability/Vets and maintains a drug-free workplace.
