Supplier Quality Engineer

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

Benefits offered by this job

PTO

401k

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips in Colorado Springs is seeking a Supplier Quality Engineer to support supplier qualification, audits, and APQP/PPAP activities within the Image Guided Therapies - Devices business. You will drive PFMEA, SPC, and process validation, while leading supplier performance improvements and SCAR actions.

The role requires 1+ years in regulated environments, knowledge of medical device regulations, and a bachelor’s degree in quality/engineering. Travel up to 10% may be required.

Qualifications

• Minimum of 1+ years’ experience in Supplier Quality/Quality Engineering within highly regulated product environments (Medical Device preferred).
• Knowledge of medical device regulations and QMS standards such as 21 CFR 803, 806, 820; ISO 13485; ISO 14971; EU MDR and Canadian regulations.
• Experience using data analytics/KPIs to assess supplier performance and drive process improvements.
• Strong communication and collaboration across internal and external stakeholders including suppliers and regulatory bodies.
• Bachelor’s Degree in Quality, Engineering, or related field; ASQ and/or Six Sigma DfX certifications are desirable.
• Ability to perform minimum physical, cognitive, environmental requirements.

Responsibilities

• Executes MSA, PFMEA, Control Plan, SPC, PV&V, FAI as part of APQP/PPAP and SICR activities.
• Supports PPAP/APQP deliverables including IQ/OQ/PQ or process validation at suppliers.
• Supports supplier improvement and development on APQP, providing guidance to enhance quality processes.
• Conducts supplier audits for initial qualification and for-cause assessments.
• Qualifies new suppliers for the Approved Supplier List and onboarding.
• Supports investigation and disposition of supplier non-conformances, containment, and escalation.
• Initiates, coordinates, and monitors SCAR processes ensuring root cause analysis and corrective actions.

Skills

APQP/PPAP

PFMEA

MSA

SPC

SCAR

CAPA

Data analytics

KPIs

Cross-functional collaboration

Communication skills

Education

Bachelor's Degree

ASQ Six Sigma (DfX) Certification

Tools

Quality systems regulations knowledge

Job description

Supplier Quality Engineer

Job Description

The Supplier Quality Engineer supports supplier qualification, supplier audits, Approved Supplier List onboarding, APQP / PPAP execution, process validation, and supplier improvement initiatives within the Image Guided Therapies - Devices business.

Your role:

• Executes MSA (Measurement System Analysis), PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation and Verification), FAI (First Article Inspection), as part of APQP (Advanced Product Quality Planning) / PPAP activities and SICR (Supplier Initiated Change Request).
• Supports PPAP/ APQP (Advanced Product Quality Planning) processes/deliverables including IQ/OQ/PQ or process validation activities at the supplier.
• Supports supplier improvement and development on APQP, providing guidance and resources to help suppliers enhance their quality processes and achieve compliance.
• Conducts supplier audits, including initial qualification and for-cause, to assess supplier compliance with applicable quality system requirements, regulatory expectations, process controls, and supplier agreement obligations.
• Qualifies new suppliers for addition to the Approved Supplier List, including assessment of supplier capability, quality system maturity, technical readiness, risk classification, approval documentation, and completion of required onboarding activities.
• Supports investigation and disposition of supplier-related non-conformances, including defect analysis, supplier-cause determination, containment, risk assessment, and escalation as needed.
• Initiates, coordinates, and monitors Supplier Corrective Action Requests (SCAR), ensuring effective root cause analysis, corrective/preventive action implementation, verification of effectiveness, and timely closure.

You're the right fit if:

• You have a minimum of 1+ years’ experience in Supplier Quality/Quality Engineering within highly regulated product environments (Medical Device preferred), with a focus on supplier selection, performance assessment, APQP, Risk Assessments/PFMEA’s, SPC, SCAR’s, SICR, CAPA, Remediation etc.
• You have knowledge of medical device regulations, QMS requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282).
• You have proven experience utilizing data analytics/KPI’s to assess supplier performance and identify/drive process improvement opportunities.
• You have strong communication/collaboration skills and the proven ability to effectively communicate, influence and build relationships cross-functionally with a variety of internal/external stakeholders, suppliers, Regulatory Agencies, Notified Bodies etc.
• You have a minimum of a Bachelor’s Degree (Required) in Quality, Engineering, or related disciplines. ASQ and/or Six Sigma DfX 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 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.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

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.

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.
• This role may require travel up to 10%.

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