Process Quality Engineer

Philips Iberica SAU; Colorado Springs (CO); On-site; USD 63,000 - 100,000; Full time

Benefits offered by this job

PTO

401k (match)

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips is hiring a Process Quality Engineer for our Colorado Springs site. The role focuses on high-quality performance, compliance and continuous improvement in a regulated environment, with responsibilities spanning NC/QN analysis, CAPA execution, PFMEA support, and NPI/product transfers.

You will apply advanced statistics to analyze trends, validate processes, and deliver metrics to stakeholders while collaborating with R&D, suppliers, and manufacturing to elevate product quality.

Qualifications

• Minimum 1+ years’ experience in highly regulated product/manufacturing environments (FDA-Medical Device preferred) with focus on Quality/Process Engineering, Continuous Improvement, Design Transfers, CAPA.
• Internship or co-op experience in quality engineering within ISO regulated environments.
• Ability to exercise good judgment within defined procedures/policies to determine appropriate action.

Responsibilities

• Analyzes defects to determine dispositions and manages NCs and QNs; implements effective CAPA actions.
• Supports PFMEA impact assessment and controls related to design changes; assists in Manufacturing Process Development and Design Transfer activities.
• Coordinates quality engineering tasks, ensures manufacturing quality systems are maintained, and assists in NPI and product transfers.
• Applies advanced statistical analysis to interpret data trends and resolve medium to high complexity requests.
• Ensures execution of process validation protocols and supports process improvements.
• Prepares quality metrics and reports for stakeholders, highlighting trends and areas for improvement.
• Participates in investigations and collaborates with suppliers, R&D, and manufacturing to resolve quality issues.

Skills

Quality engineering

CAPA

PFMEA

Root cause analysis

Statistical analysis

Regulated environment

Education

Bachelor's degree in engineering

Job description

Job Title

Process Quality Engineer

Job Description

The Process Quality Engineer supports and facilitates high-quality performance, compliance and continuous/process improvement at our Image Guided Therapy Devices (IGTD) Colorado Springs manufacturing site.

Your Role:

• Analyzes defects for determining dispositions/drives management of Non-Conformances (NC) and Quality Notifications (QN) and implements effective Corrective and Preventive Actions (CAPA) actions. Assists in the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.

• Supports operations performance monitoring, risk assessment, reporting, improvement and development, aids with improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and purchasing.

• Coordinates timely quality engineering and quality assurance tasks, aids in ensuring manufacturing quality systems are maintained, and helps in completion of New Product Introduction (NPI) and product transfers in factory.

• Identifies transformative process enhancement opportunities, facilitating the execution of advanced improvement initiatives to optimize operational performance and elevate product quality benchmarks significantly. Applies advanced statistical analysis techniques proficiently to interpret complex data trends and resolve medium to high complexity requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.

• Ensures the comprehensive execution of process validation protocols, coordinates multifaceted production activities to bolster process validation efforts and drive continuous process improvements effectively.

• Prepares and delivers detailed quality metrics and reports to key stakeholders, highlighting significant achievements, emerging trends, and targeted areas for advanced improvement initiatives and regulatory compliance strategies.

• Participates in investigations and collaborates with suppliers, Research and Development (R&D), and manufacturing teams to resolve quality issues and maintain high standards throughout the supply chain.

You're the right fit if:

• You have a minimum of 1+ years’ experience working in highly regulated product/manufacturing environments (FDA-Medical Device preferred) with a focus on Quality/Process Engineering, Continuous Improvement, Design Transfers, CAPA’s etc.
• You’ve acquired previous internship or co-op experience in quality engineering within ISO regulated environments.
• You’re able to exercise good judgment in working within defined procedures/policies to determine appropriate action in working with supervisors and functional peer groups to gain cooperation of others.

• You have proven experience participating in investigations and collaborating with suppliers, R&D, and manufacturing teams to resolve quality issues and maintain high standards throughout the supply chain.

• You have experience in Risk Assessment (ISO 14971), Process Failure Mode and Effects Analysis (PFMEA) and Root Cause Analysis.

• You have experience applying statistical/data analysis techniques to interpret complex data trends, performance monitoring, reporting and resolving medium to high complexity requests.

• You have a minimum of a Bachelor’s Degree in Engineering-Required. ASQ certifications are 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 (5 Days per week) 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 On-site 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 culture of impact with care.

Philips Transparency Details:

• The pay range for this position in Colorado Springs, CO is $63,000 to $100,000

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 Colorado Springs, CO.

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Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.