Quality Inspector jobs in United States, Colorado, Colorado Springs

Your role

• Learn and support global Post Market Surveillance including complaint intake, investigation, Vigilance reporting, record review, record closure, Issue Impact assessments, Correction and Removal, and Corrective and Preventive Actions.
• Evaluate and resolve complaints, initiate Issue Impact Assessments and CAPAs, analyze complaint data, other additional data as needed.
• Provide feedback and support as the team improves and aligns the Post Market process for Philips IGTD
• You will work with the global Post Market unit which interacts with all quality departments, Research & Development, Clinical/Med Affairs, Engineering and Senior Management.
• Gain real life experience in a regulated industry, exposure and interaction with cross functional departments globally.

You're the right fit if

• You are pursuing a Science, Technology, Engineering, or Math based undergraduate degree with at least 2 years of education completed
• Your skills include technical knowledge, communication, research and critical thinking, problem solving attention to detail, resilience, and teamwork
• You’ve acquired 2+ years of experience in college/University and/or previous internships or coops, no direct work experience necessary just a desire to learn and work in a team as an individual contributor
• 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
• You’re eager to learn and drive for results
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

How we work together

This is an office role.

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 .
• Discover
• Learn more about
• Learn more about .

The hourly pay range for this position is $25.00 to $28.00, plus overtime eligible. 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.

Details about our benefits can be found .

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.

be provided for this position. For this position, you must reside in

In this role you

You are responsible for creating and executing comprehensive process validation strategies to ensure new products transition seamlessly to production, adhering to quality and regulatory standards. The role executes the full design control process, including validation and design transfer, and ensures accurate and up-to-date quality engineering documentation.

Your role:

• Creates and executes comprehensive Design Test Method Validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
• Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
• Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.

You're the right fit if:

• Bachelor's Degree/ Master's Degree inMechanical Engineering, Electronics Engineering, Science or equivalent.
• Minimum 2+ years experience in Design Quality Management in Medical Device.
• Prefer 5+ years of experience with Design, Test Validation, Usability, Reliability, Performance, Manufacturability, Safety, Audit, CAPA.
• 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

This is an office role.

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 .
• Discover
• Learn more about
• Learn more about

.

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.

will notbe provided for this position. For this position, you must reside in

You will sustain and maintain labeling system software, hardware and processes in a medical device manufacturing environment.

Your role:

• Develop and maintain a complete labeling system (software, processes and equipment) for complex medical devices.

• You are responsible for: the development sustaining of a complete labeling system solution software; the quality and compliance of medical device labeling; internal and external database management; validation activities (software and hardware); and departmental work instructions/processes.

• Deployment and administration of a complete labeling system, including documented Work Instructions (WIs) and departmental Standard Operating Procedures (SOPs).

• Ensuring timely change management of labeling and Instructions For Use (IFUs), working with labeling technicians/label coordinators, and performing labeling changes.

• Quality management and all life-cycle phases of product labeling and IFUs. Leadership, both direct and indirect, will be an expectation of this role as a growth path.

You're the right fit if:

• You’ve acquired 1+ year of engineering experience in medical device or other highly regulated industry.
  Your skills include supporting quality related investigations and changes involving labeling materials and/or labeling processes, such as NCRs, CAPA, SICRs, IIAs, Audit Support questions, Equipment Events, Regulatory Gap Assessments, etc.

• You have a B.S. in Engineering.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You’re an excellent communicator that is detail oriented and well organized.

How we work together:

This is an office-based role.

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 .

• Discover

• Learn more about

• Learn more about

The pay range for this position in CO is $71,250 to $114,000

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 Plymouth, MN .

Your role

Work with all key suppliers of Image Guided Therapy and Cross Functional teams (R&D and Quality) to enhance Supplier maturity through Design Quality and Product Quality.

• Analysis of defects for determining if supplier caused

• Support Supplier Corrective Action Requests

• Support APQP deliverables as parts of Sustaining Changes

• Contribute to Supplier performance monitoring, reporting, improvement and development

• Supports with Additions/Changes/Deletion to Approved Supplier List

• Support Supplier audit schedule development and maintenance.

• Assess and coordinate Supplier Change Requests.

You are the right fit if

• You are pursuing a technical engineering deree: Bachelor or Master Degree of Industrial Engineering, Chemical Engineering, Electrical, Mechanical or similar.

• Experience to driving root cause analysis to perform problem solving strategies

• Work closely with cross functional team and SQEs across all sites of IGTD to address none-conformances.

• Visit Suppliers as needed to review corrective actions.

• Review Design of parts to understand impact to patient safety.

• 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

This is an office role.

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 .
• Discover
• Learn more about
• Learn more about .

The hourly pay range for this position is $25.00 to $28.00, plus overtime eligible. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Details about our benefits can be found .

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.

be provided for this position. For this position, you must reside in

The Quality Inspector performs tasks that support the execution of the regulatory quality control process.

Your role:

• Conduct Inspection of random stages to ensure compliance to drawing and process.

• Report noncompliance issues, raise reports for non-conforming product detected at the goods-in stage and support production detected nonconformities when required and action solutions

• Provide ad-hoc business support against specific demand for Inspection/measurement of product where required

• Ensuring appropriate levels of product and process inspections occur as defined in QMS processes

• Providing real time feedback to quality and manufacturing management on issues that may affect the quality of incoming, outgoing materials or product.

You're the right fit if:

• You’ve some experience working a Quality Control position, 6+ months experience preferred

• Your skills include experience utilizing tools such as micrometers, pin gauges, surface height indicators and digital and manual calipers, as well as the ability to read engineering drawings, product specifications, receiving inspection plans, and test procedures; understand Zero Acceptance Sampling Plans using AQL sampling and 100% inspection.

• You have a high school diploma or equivalent

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

• You’re a self starter with strong computer abilities: web-based systems, Microsoft Office, Material and Document Control Software

How we work together

This is an onsite role.

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 .

• Discover

• Learn more about

• Learn more about

The pay range for this position in Colorado is $18.39 to $29.42

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.

Your Role:

• Responsible for Leading, Supervising, Developing and budgetary management for the Image Guided Therapy Devices (IGTD) Quality Operations team supporting acceptance activities, manufacturing, complaint investigations, labeling, packaging, calibration, sterilization, NPI and microbiology.
• Will provide direction and partner with cross functional teams in root cause analysis and issue resolution related to manufacturing, quality management systems, and compliance. Responsible for overseeing tracking and trending of the site’s quality performance data and provides direction on issue resolution for negative trends and results.
• Will serve as the subject matter expert for the site’s quality metrics (nonconformances, CAPAs, complaint investigations, training, etc), operating procedures, and work instructions for internal discussions and internal and external audits.
• As part of continuous improvements to the quality management system, optimizes, reviews and approves procedures, work instructions, protocols and reports for the manufacturing site, including but not limited to process validation and equipment qualifications.
• Will partner with Business and Operations team members in product transfers, new product development and continuous improvement projects, as well as manufacturing and supply chain in product quality improvements, including but not limited to product yield and Cost of Non-Quality measures.
• Establishes and manages the necessary quality programs to meet the Quality System and Quality Assurance needs per company procedures and applicable federal regulations and international standards
• Work with cross functional teams on operations quality mentorship programs, development and succession planning and manages quality budget in accordance with Philips requirements

You're the right fit if:

• You have a minimum of 10+ years’ Quality Operations experience within FDA regulated medical device environments, with a focus on manufacturing, complaints/PMS, labeling, packaging, calibration, sterilization, NPI and microbiology, with a minimum of 5+ years’ experience in Strategic-Functional leadership, change management, people development and budgetary management for Operations quality teams/organizations.
• You have detailed knowledge of cGMP, GDP, FDA and ISO13485 requirements.
• You have the proven ability to work with senior/executive leaders and engage/influence cross functional leadership teams.
• You’re proactive, detail-oriented, and comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
• You’ve earned a minimum of a Bachelor’s Degree (required) in Life Sciences, Engineering, Quality or related disciplines. Master’s degree desired. ASQ CQE, CBA, or CQA and Six Sigma certifications-preferred
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

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 .
• Discover
• Learn more about
• Learn more about

Philips Transparency Details:

• The pay range for this position in Colorado Springs, CO is $153,000 to $246,000.

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.