Supplier Quality Engineer jobs at GE Healthcare Holdings Inc.

At Houston Methodist, the Senior Quality Outcomes Specialist position is responsible for assessing and facilitating clinical systems and/or processes to ensure that care delivered is safe, effective, patient-centered, timely, efficient and equitable. This position identifies outcomes variances, taking initiative for timely resolution of potential concerns, and utilizes the ability to synthesize an analysis of complex systems, developing and implementing solutions to improve complex processes and goals. Other responsibilities include supporting and promoting the organization-wide clinical performance improvement/patient safety program and culture; and serving as departmental expert for areas of expertise, sharing knowledge, effective tools and educational materials as appropriate. Additionally, this position serves as a resource and expert in performance improvement methodologies to clinical staff; conducts educational offerings to support training, mentoring, and precepting of team members; and conducts review, analysis, and integration of data in workflow design to support team, departmental and organizational mission and goals. PEOPLE ESSENTIAL FUNCTIONS Promotes organization-wide understanding of overall quality and patient safety program and culture. Serves as an expert resource to all levels of the organization regarding quality improvement activities. Proactively and effectively develops and maintains collaborative relationships with physicians, hospital leaders and staff. Serves as operational liaison to physicians and staff to support Care Management Performance Improvement (CMPI)/Project goals. Facilitates a multidisciplinary approach to improve clinical processes and outcomes. Makes recommendations to key leadership for team strategies to achieve desired outcomes. Serves as a lead resource and mentor for other Quality Outcome Specialists. May assist in creating and reviewing project designs. SERVICE ESSENTIAL FUNCTIONS Serves as a key quality contact with leadership, managers and staff responsible for the execution of corrective actions initiatives/projects and compliance with customer requirements. Supports leadership with the development and implementation of patient safety and process improvement changes. Makes recommendations for unit-based process change initiatives. QUALITY/SAFETY ESSENTIAL FUNCTIONS Facilitates timely and effective resolutions of patient care process issues. Uses performance improvement methodologies in the development of performance improvement/patient safety initiatives and coordinates teams as needed to drive change towards desired outcomes. Monitors compliance with clinical protocols, pathways and evidence-based care along the continuum for various hospital patient populations. Facilitates a multi-disciplinary approach to improve clinical process and outcomes. Monitors and evaluates clinical performance of CMPI and Project efforts using defined metrics and desired outcomes. Makes recommendations to key leadership for team strategies to achieve desired outcomes. Abstracts pertinent information and enters into department databases using standardized methods and processes. Routinely performs discrepancy management activities to maintain data integrity. Presents meaningful reports and analysis with measurement description, statistical information, and benchmarking information. Monitors trends and provides feedback. Creates and presents executive summaries as needed to various audiences to drive change. Supports improvement efforts for potential or actual quality of care issues including participation/facilitation of Root Cause Analysis (RCA), Failure Modes Effects Analysis (FMEA), Critical Incident Review (CIR) or event review as needed. Supports leadership and staff with the development and implementation of process changes. Conducts evaluation of effectiveness of initiatives and presents findings as needed. Facilitates systems' design to hardwire patient safety processes. FINANCE ESSENTIAL FUNCTIONS Facilitates performance improvement projects/initiatives to improve outcomes, ultimately impacting hospital finances. GROWTH/INNOVATION ESSENTIAL FUNCTIONS Identifies and recommends opportunities for improvement in accordance with hospital leadership. Assists in the development of long-term tactics and strategies to improve operational processes. Analyzes and assesses present and future needs, trends, challenges, and opportunities related to hospital processes and operations. This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises. EDUCATION Bachelor's degree in nursing Master's degree preferred WORK EXPERIENCE Four years of experience in direct patient care activities in a hospital setting Three years of experience in Hospital Quality Improvement Two years of progressive leadership experience LICENSES AND CERTIFICATIONS - REQUIRED RN - Registered Nurse - Texas State Licensure -- Compact Licensure - Must obtain permanent Texas license within 60 days (if establishing Texas residency) AND Certification: CPHQ, CPPS, or CPSO within 18 months KNOWLEDGE, SKILLS, AND ABILITIES Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles Demonstrates knowledge and application of process improvement tools and techniques (statistical process control tools and team tools) Demonstrates knowledge of regulatory and accrediting standards as they apply to performance improvement Skill in developing and maintaining interpersonal relationships with a wide variety of healthcare professionals and hospital leadership Ability to define problems, collect data, establish facts and draw valid conclusions and evidence performance improvement via measurable results Ability to enter and abstract data using personal computer, as well as the ability to utilize data to facilitate the improvement and change in processes Computer skills to include Excel, Word, and PowerPoint Ability to facilitate performance improvement teams, present data and promote a collaborative approach toward goal achievement Ability to work independently and interdependently Presentation skills and expertise in designing and implementing teams/educational offerings related to clinical quality SUPPLEMENTAL REQUIREMENTS WORK ATTIRE Uniform No Scrubs No Business professional Yes Other (department approved) No ON-CALL* *Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below. On Call* No TRAVEL** **Travel specifications may vary by department** May require travel within the Houston Metropolitan area Yes May require travel outside Houston Metropolitan area No Company Profile: Houston Methodist Willowbrook Hospital is a Magnet-recognized, not-for-profit, faith-based hospital that serves the growing Northwest Houston community. With 358 licensed beds, Houston Methodist Willowbrook is committed to providing quality, cost-effective health care in a compassionate environment for a full range of services, including emergency care, cardiology, orthopedics and sports medicine, comprehensive women's services, neurology and neurosurgery, oncology, and primary and general medicine. Houston Methodist is an Equal Opportunity Employer.

The achievers and courageous challenge-crushers we seek, have the following characteristics and skills: What You will Do: Quest Global is seeking a highly organized and detail-oriented Quality Engineer to join our team. In this role, you will ensure compliance with quality standards and continuous improvement within Gas Turbines Rotor Components Machining Department. This role involves monitoring manufacturing processes, conducting root cause analysis, and implementing corrective/preventive actions to maintain product integrity and customer satisfaction. The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:• What You Will Do: Quality Assurance & Compliance Develop, implement, and maintain quality control procedures for rotor components machining processes. Ensure adherence to Siemens Energy quality standards and applicable industry standards. Inspection & Documentation Review engineering drawings, specifications, Prepare and maintain quality documentation, inspection reports, and RCAs, Corrective / preventive action records. Root Cause Analysis & Problem Solving Lead investigations using RCA, 8D, and CAPA methodologies for non-conformances. Drive corrective and preventive actions to eliminate recurring issues. Process Audits & Continuous Improvement Conduct internal/process audits of machining processes and identify improvement opportunities. Support Lean initiatives and process optimization projects. Collaboration & Communication Work closely with manufacturing engineers, machinists, and supervisors to resolve quality issues. Provide technical guidance and training on quality standards and best practices. What You Will Bring: Bachelor's degree in mechanical or manufacturing engineering. Minimum 7 years of experience in quality engineering within a machining or heavy manufacturing environment. Proficiency in quality tools: RCA, FMEA, PPAP and SPC Good understanding of CAD/CAM, CNC programming, and interpreting technical drawings with GD&T Strong knowledge of machining processes, CNC, CMM and precision components. Familiarity with SAP or similar ERP systems and Microsoft Office Suite. Certification in Six Sigma will be an added advantage Strong interpersonal skills Analytical and problem-solving skills with attention to detail. Ability to interpret complex engineering drawings and specifications. Strong communication and interpersonal skills for cross-functional collaboration. Knowledge of industry standards and regulatory requirements for turbine components. Ability to apply continuous improvement methods to increase manufacturing quality, efficiency, reliability, and cost effectiveness. Experience with advanced manufacturing processes Candidate should be familiar with Lean and or Six Sigma philosophies and their application in process capability and improvement Pay Range: (75K to 80K ). Compensation decisions are made based on factors including experience, skills, education, and other job-related factors, in accordance with our internal pay structure. We also offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan. Work Requirements: This role is considered an on-site position located in Charlotte, NC. You must be able to commute to and from the location with your own transportation arrangements to meet the required working hours. Shop floor environment, which may include but not limited to extensive walking, and ability to lift up to 40 lbs.

We're a “safety first high performance” culture driven by a zero waste and zero defect mentality set out to enrich the lives of humans everywhere. As a leading vitamin and food supplement manufacturer, we carry on the legacy of our Founder who led us to reshape the category. We have grown our passionate Piping Rock Family as we've grown our business. We are growing quickly, join the Piping Rock family and grow your career. As a Process Engineer, you'll be responsible for equipment re-design while implementing, controlling, and optimizing packaging/manufacturing processes and machinery to achieve organizational targets. You'll work hand in hand with Production and Engineering to help improve standards that enable high performing production processes in our facility. Additional responsibilities include defining equipment standards, leading process and benchmarking and reapplication, and building capability within teams to do technical troubleshooting and process improvement and understanding the Piping Rock Continuous Excellence program and the respective tools. Responsibilities: Analyze production loss data to identify and prioritize projects to be executed in factory's continuous improvement plan and develop technical mastery of the core production processes, driven by bottleneck/high losses. Lead v-curve analysis and balanced line flow studies and identify debottlenecking projects. Initiate, lead, and modify process/improvements that will increase throughput, reduce scrap, improve quality, and eliminate losses. Implement LEAN manufacturing methods. Drive and mobilize resources to conduct problem solving on systems or equipment through failure modes & effects analysis (FMEA) and other Six Sigma methodology. Develop productivity standards, collect data to publish KPI and OEE reports. Participate in planning, commissioning, and startup of new equipment/processes. Creating and improving standards that enable sustainability of high preforming production processes and supporting training programs that develop high performing operators and technicians and. Collaborating with technical experts, other functions, and other factories to create and replicate optimal solutions/best practices. Establish operating parameters for each equipment by product to obtain reliable and efficient production Responsible for working directly on the manufacturing lines and assisting mechanics during repairs to understand the process workflow. Work schedule flexibility to overlap with other shifts as needed. Other duties as assigned. Qualifications: Bachelor's degree in an engineering field, preferably Industrial and Systems Engineering 3+ years of project/ process management experience in a manufacturing, or packaging environment. Or Associates degree in a technical field. 7+ years of project/ process management experience in a manufacturing, or packaging environment. Preferred Skills: Six Sigma or Lean certification. Experience with process automation and control systems. GMP environment a plus Must be able to lift 30lbs Must be able to stand for 8 hours Must be able to work in a physically challenging environment. We proudly offer: Medical, Dental, Vision, 401K with Company Match, Pet insurance and more! We reward the hard work of our team members with fun and exciting company events, Summer Picnic, Festive Packages, Holiday Celebrations, and associate referral bonuses! Founded in 2011, Piping Rock Health Products has gone on to win Long Island's Top Workplaces Award 6 years in a row & securing the spot as Top Supplement Manufacturing Company 2024 by Food Business Review! Supported by a group of vitamin visionaries with over 40 years of industry experience and a carefully curated team of talented associates. Piping Rock is a global vitamin and supplement manufacturer with an unwavering commitment to creating quality wellness products. We believe that family always comes first, and that the dedication of our associates is the key ingredient to our success. We are drug free workplace, regulated by the FDA, required to follow Federal Guidelines; therefore in order to start as well as maintain employment, you must be able to successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines. Piping Rock Health Products, INC is an Equal Opportunity Employer.

Marlborough, MA, United States Are you passionate about ensuring the quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role, you'll lead investigations into post-market feedback and complaints, conduct root cause analyses, and implement corrective or preventive actions to ensure our products meet the highest standards of quality and safety. Collaborating with cross-functional teams, you'll drive product and process improvements while making a meaningful impact on the lives of patients worldwide. If you're a proactive problem-solver with experience in quality, risk management, and engineering, we'd love to have you on our team! **Knowledge:** + Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. + In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). + Familiarity with test method validation, root cause failure analysis, and statistical methods. + Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components. + Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards. **Skills:** + Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs). + Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact. + Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation. + Ability to perform independent health risk assessments and present findings to leadership. + Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership. + Strong ability to assess and review written product and project documentation for compliance. + Preferred: Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products. **Behaviors:** + Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. + Proactive and decisive, with the ability to independently prioritize tasks and resolve conflicts. + Collaborative and team-oriented, with a focus on fostering productive working relationships across functions. + Problem-solving mindset, focused on identifying root causes and driving effective solutions. + Customer-focused, with a commitment to addressing product quality issues and ensuring customer satisfaction. + Driven by continuous improvement, with a desire to optimize processes and enhance product quality. **Experience:** + **5+ years** of experience in engineering, preferably in a regulated industry such as medical devices. + Hands-on experience with root cause analysis, product development, or R&D. + Beneficial experience includes supporting complex medical devices (e.g., software, electromechanical systems) at the system level. **Education:** + Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field). **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. **Agency and Third-Party Recruiter Notice** _Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._ **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-NT1

Are you passionate about ensuring the quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role, you'll lead investigations into post-market feedback and complaints, conduct root cause analyses, and implement corrective or preventive actions to ensure our products meet the highest standards of quality and safety. Collaborating with cross-functional teams, you'll drive product and process improvements while making a meaningful impact on the lives of patients worldwide. If you're a proactive problem-solver with experience in quality, risk management, and engineering, we'd love to have you on our team! Knowledge: Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). Familiarity with test method validation, root cause failure analysis, and statistical methods. Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components. Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards. Skills: Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs). Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact. Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation. Ability to perform independent health risk assessments and present findings to leadership. Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership. Strong ability to assess and review written product and project documentation for compliance. Preferred: Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products. Behaviors: Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. Proactive and decisive, with the ability to independently prioritize tasks and resolve conflicts. Collaborative and team-oriented, with a focus on fostering productive working relationships across functions. Problem-solving mindset, focused on identifying root causes and driving effective solutions. Customer-focused, with a commitment to addressing product quality issues and ensuring customer satisfaction. Driven by continuous improvement, with a desire to optimize processes and enhance product quality. Experience: 5+ years of experience in engineering, preferably in a regulated industry such as medical devices. Hands-on experience with root cause analysis, product development, or R&D. Beneficial experience includes supporting complex medical devices (e.g., software, electromechanical systems) at the system level. Education: Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field). Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1

Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Senior Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive actions to improve product performance. Collaborating with cross-functional teams, you'll contribute to product design, process improvements, and regulatory compliance while making a meaningful impact on patient safety and satisfaction. If you're a proactive problem-solver with a strong background in quality engineering, we encourage you to apply! Knowledge: Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Knowledge of root cause analysis tools and risk-based decision-making processes. Preferred: Familiarity with test method validation, statistical methods, and standards related to reliability, electrical safety, sterilization, packaging, and biocompatibility. Skills: Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues and improve product performance. Strong data analysis and trending skills to identify patterns, assess risks, and recommend mitigations. Ability to manage and implement design or process changes, including testing, documentation, and change control. Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership. Ability to collaborate with cross-functional teams, including Operations, Engineering, and R&D, to drive improvements in product design and manufacturing processes. Preferred: Experience with statistical tools, design of experiments (DOE), and verification/validation requirements for regulated products. Behaviors: Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements. Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes. Collaborative and team-oriented, building productive relationships across functions to drive quality improvements. Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution. Continuous improvement mindset, actively identifying opportunities to enhance processes and product quality. Experience: Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline) required. 5+ years of experience with a Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering. 1-3 years of experience with a Master's degree, or 0-1 year with a PhD in a related field. Experience in an FDA-regulated industry preferred. Hands-on experience in root cause analysis, complaint investigations, and product development or R&D is beneficial. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1

At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary The Supplier Quality Engineer is primarily responsible for ensuring the needs of internal customers are met by Caris' suppliers, working to address quality issues and providing technical support related to the quality system assessment and performance evaluation. This role applies a risk-based approach to supplier monitoring, qualification and assessment, working closely with functional groups help drive corrective action when necessary. The Supplier Quality Engineer acts as a liaison between Caris and its suppliers to ensure product quality and continuous improvement. Job Responsibilities Responsible for the appropriate qualification and on-going monitoring of Caris' suppliers Assist in performing supplier audits providing subject matter expertise. Can lead supplier audits based on auditor qualifications. Assess and critique supplier process control documentation, identifying areas of improvement and driving improvement within the suppliers' QMS. Open and assist with Supplier Corrective Action Request, ensuring effective use of appropriate problem-solving tools. Performs critical assessment of internal and supplier proposed change management activities. Provide education and training to suppliers as necessary. Provide problem solving expertise at site and supplier locations in support of critical quality issues. Assist with development of effective quality improvement plans to be implemented at appropriate suppliers. Collaborate with internal teams to gather assessments for supplier-initiated changes requests for continuous improvement, cost reduction or supplier remediation activities. Support tracking and reporting of KPI and other metrics associated with supplier performance. Articulate detailed supplier performance results and trends to appropriate levels of management. Perform detailed process reviews at supplier's manufacturing site. Maintain and track to completion closure of assigned supplier action items. Develop relationships with suppliers and internal cross functional partners Analyze non-conformance data to prioritize projects and to solve systemic supplier issues Assist, as needed, to perform other related duties and special projects as required Required Qualifications Bachelor's degree in engineering required Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics). Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use. Preferred Qualifications A minimum of 3 years of experience working within FDA regulated (Medical Device) or regulated industries (Automotive, Aerospace) highly preferred. Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements). Physical Demands Employee may be required to lift routine office supplies and use standard office equipment. Ability to sit for extended periods of time. Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other This position requires periodic travel and some evenings, weekends and/or holidays. Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

As a Supplier Quality Engineer I at Penumbra, you will play a key role in ensuring our supply chain consistently delivers components and materials that meet the highest standards of quality and compliance. Working closely with cross-functional partners in Operations, Compliance, and R&D, you will support supplier qualifications, changes, corrective actions, and performance monitoring. You'll help resolve supplier-related issues, drive improvements, and ensure adherence to Penumbra's Quality Management System (QMS) and regulatory requirements. This is an excellent opportunity for an early-career engineer to build a strong foundation in supplier quality, gain exposure to medical device manufacturing, and grow within a high-impact quality organization. You'll join a collaborative and growing Quality organization that invests in technical development and career growth. What You'll Work On * Support day-to-day supplier quality issues and coordinate with Engineering and Operations to communicate and collaborate with suppliers. * Provide technical and quality support for Incoming Quality Control (IQC) and contribute to improvement initiatives for supplier and IQC processes. * Participate in the alignment of supplier inspection and testing methods with Penumbra's internal methodologies. * Investigate supplier-related failures (e.g., IQC nonconformances) and support corrective and preventive actions. * Assist in Supplier Corrective Action Requests (SCARs), Second Source Qualifications (SSQs), and Supplier Change (SC) activities, including risk assessments and documentation. * Initiate and manage Supplier Notifications (SNs) and track supplier quality actions to closure. * Support the monitoring and trending of supplier performance metrics to identify improvement opportunities. * Assist with qualification and ongoing management of suppliers on the Approved Supplier List (ASL). * Ensure adherence to Penumbra's QMS and applicable domestic and international regulations (e.g., QSR, ISO 13485). * Collaborate cross-functionally to strengthen supplier partnerships and drive continuous improvement in product quality and reliability. Position Qualifications * Bachelor's degree in engineering, science, or a related field. * 0-3 years of experience in Quality, Manufacturing, or Engineering; prior exposure to a regulated industry (medical device, pharmaceutical, aerospace, etc.) preferred. * Foundational knowledge of quality systems (QSR, ISO 13485) and risk-based quality principles. * Strong analytical and problem-solving skills with an interest in statistical methods. * Excellent written and verbal communication skills, with the ability to work collaboratively across teams and suppliers. * Proficiency with standard business tools (Excel, Word, PowerPoint, and statistical software). Location and Pay * Alameda, CA * Starting Base Salary: $76,000/year to $100,000/year What You Bring * A passion for detailed analysis and problem solving. * A desire for growing project management skills and a drive to plan and execute projects that align with business needs. * The desire to be part of a great team and to support Supplier Quality Engineering on cross-functional technical teams. * The ability to lead with humility, a collaborative mindset, and confidence. * Strong oral, written, and interpersonal communication skills. * The ability to present issues, plans, and objectives in a clear, both orally and in writing. * Versatility, flexibility, and a willingness to work within changing priorities. Working Conditions * General office, laboratory, and cleanroom environments * Willingness and ability to work on site. * Business travel from 10% - 20% * Potential exposure to blood-borne pathogens * Requires some lifting and moving of up to 25 pounds * Must be able to move between buildings and floors. * Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. * Must be able to read, prepare emails, and produce documents and spreadsheets. * Must be able to move within the office and access file cabinets or supplies, as needed. What We Offer * A collaborative teamwork environment where learning is constant, and performance is rewarded. * The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. * A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.

General SummaryAs a Supplier Quality Engineer I at Penumbra, you will play a key role in ensuring our supply chain consistently delivers components and materials that meet the highest standards of quality and compliance. Working closely with cross-functional partners in Operations, Compliance, and R&D, you will support supplier qualifications, changes, corrective actions, and performance monitoring. You'll help resolve supplier-related issues, drive improvements, and ensure adherence to Penumbra's Quality Management System (QMS) and regulatory requirements. This is an excellent opportunity for an early-career engineer to build a strong foundation in supplier quality, gain exposure to medical device manufacturing, and grow within a high-impact quality organization. You'll join a collaborative and growing Quality organization that invests in technical development and career growth. What You'll Work On• Support day-to-day supplier quality issues and coordinate with Engineering and Operations to communicate and collaborate with suppliers.• Provide technical and quality support for Incoming Quality Control (IQC) and contribute to improvement initiatives for supplier and IQC processes.• Participate in the alignment of supplier inspection and testing methods with Penumbra's internal methodologies.• Investigate supplier-related failures (e.g., IQC nonconformances) and support corrective and preventive actions.• Assist in Supplier Corrective Action Requests (SCARs), Second Source Qualifications (SSQs), and Supplier Change (SC) activities, including risk assessments and documentation.• Initiate and manage Supplier Notifications (SNs) and track supplier quality actions to closure.• Support the monitoring and trending of supplier performance metrics to identify improvement opportunities.• Assist with qualification and ongoing management of suppliers on the Approved Supplier List (ASL).• Ensure adherence to Penumbra's QMS and applicable domestic and international regulations (e.g., QSR, ISO 13485).• Collaborate cross-functionally to strengthen supplier partnerships and drive continuous improvement in product quality and reliability. Position Qualifications• Bachelor's degree in engineering, science, or a related field.• 0-3 years of experience in Quality, Manufacturing, or Engineering; prior exposure to a regulated industry (medical device, pharmaceutical, aerospace, etc.) preferred.• Foundational knowledge of quality systems (QSR, ISO 13485) and risk-based quality principles.• Strong analytical and problem-solving skills with an interest in statistical methods.• Excellent written and verbal communication skills, with the ability to work collaboratively across teams and suppliers.• Proficiency with standard business tools (Excel, Word, PowerPoint, and statistical software). Location and Pay• Alameda, CA • Starting Base Salary: $76,000/year to $100,000/year What You Bring• A passion for detailed analysis and problem solving.• A desire for growing project management skills and a drive to plan and execute projects that align with business needs.• The desire to be part of a great team and to support Supplier Quality Engineering on cross-functional technical teams.• The ability to lead with humility, a collaborative mindset, and confidence.• Strong oral, written, and interpersonal communication skills.• The ability to present issues, plans, and objectives in a clear, both orally and in writing.• Versatility, flexibility, and a willingness to work within changing priorities. Working Conditions• General office, laboratory, and cleanroom environments• Willingness and ability to work on site. • Business travel from 10% - 20%• Potential exposure to blood-borne pathogens• Requires some lifting and moving of up to 25 pounds• Must be able to move between buildings and floors. • Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. • Must be able to read, prepare emails, and produce documents and spreadsheets. • Must be able to move within the office and access file cabinets or supplies, as needed. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.

Who We Are Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery. A Day In The Life Of Our Sr. Product Quality Engineer at Noah Medical Able to lead efforts into the investigation of returned field devices, including flexible endoscopes, disposable devices, and capital devices/equipment Take the lead on methodical root cause analysis projects. Document the findings in clearly written reports/presentations Review engineering drawings, understand their impact on parts received, and propose opportunities for design improvements Design of test methods and fixtures in order to facilitate efficient study of returned devices Mentor less experienced engineers in the process of effective root cause analysis. Collaborate with design, manufacturing, and quality teams to drive consistent, high-quality parts and assemblies About You B.S. or M.S. in mechanical engineering or related engineering discipline Min 7 years of experience in the medical device industry Demonstrated history of applying creative problem solving ability to difficult technical problems At least 5 years of leading root cause efforts of clinical context and use of medical devices Ability to manage and analyze large sets of data and effectively communicate results of data analysis. Proficient in use of CAD Experience assessing products produced by various fabrication methods used in single use, complex medical devices(e.g. machining, plastic injection molding, MIM, laser cutting, stamping, rapid prototyping). Demonstrated ability to work and mentor successfully in a team environment. Demonstrated strong project management skills. Eagerness to learn and to contribute to state of the art technology #LI-Hybrid Pay Transparency The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives. California Pay Range$120,600-$150,800 USD Benefits & Perks (For Full Time Employees): Competitive Salary Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Equity & Bonus Program Life Insurance (company paid & supplemental) and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO + sick time Paid parental leave In-office snacks and beverages In-office lunch stipend Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws. Please visit our Careers Page to view our latest openings. NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Assist with the Corrective/Preventive Action (CAPA) program. Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d is an Equal Opportunity Employer

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Lead or assist with the Corrective Action/Preventive Action (CAPA) program. Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including leading supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Demonstrated proficiency with FDA and ISO standards for Medical Devices. Restor3d is an Equal Opportunity Employer

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Assist with the Corrective/Preventive Action (CAPA) program. • Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d/ Conformis is an Equal Opportunity Employer

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Assist with the Corrective/Preventive Action (CAPA) program. Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d is an Equal Opportunity Employer

The Product Quality Engineer will be responsible for product quality engineering/ quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing, continuous improvement, and product release activities. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Perform quality testing of CER and Purified water system. Perform product release activities (on an as needed basis). Administers the bioburden/endotoxin testing program as required per procedure. Trend in-process manufacturing data and environmental monitoring data and produce summary reports. Implement and maintain quality system in accordance to applicable regulatory requirements. Initiate and participate in resolution of non-conforming materials. Review Non-Conformity Reports for sub-assemblies and finished goods. Administer the calibration system. Review of the daily activities for production start-up. Develop and upgrade procedures for continuous improvement as required by the quality system. Perform Internal Quality Audits of the quality system. Develop qualification/validation plans. Conduct product/process validations (sterilization). Develop and implement statistical sampling plans. Assist in the investigation of product complaints. Assist in corrective action investigations. Perform internal audits to drive continuous improvement (minimum of 2 per year). Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering or Science. 1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred - with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications). Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office 2010. Knowledge of FDA and ISO standards for Medical Devices is a plus. Knowledge of Statgraphics or Minitab is a plus. Conformis is an Equal Opportunity Employer

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Lead or assist with the Corrective Action/Preventive Action (CAPA) program. Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including leading supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Demonstrated proficiency with FDA and ISO standards for Medical Devices. restor3d is an Equal Opportunity Employer

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Lead or assist with the Corrective Action/Preventive Action (CAPA) program. • Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including leading supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. • Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. • ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. • Demonstrated proficiency with FDA and ISO standards for Medical Devices. restor3d/ Conformis is an Equal Opportunity Employer

Job TitleProcess Quality EngineerJob Description The Process Quality Engineer supports and facilitates high quality performance, compliance and continuous/process improvement at our Image Guided Therapy Devices (IGTD) Rancho Cordova, CA 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. 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. You're the right fit if: You have a minimum of 2+ years' experience working in FDA regulated product/manufacturing environments, with a focus on Quality Engineering/Process Quality, Continuous Improvement, Design Transfers, CAPA's etc. 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 Bachelor's degree (Required). 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. On-site roles require full-time presence (5 days/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. Philips Transparency Details: The pay range for this position in Rancho Cordova, CA is $68,040 to $108,864. 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 Rancho Cordova, CA. #LI-PH1 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.

At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary The Process Quality Engineer ensures on-going product quality through continuous process and product monitoring, statistical analysis, and continual quality improvement initiatives. The Process Quality Engineer is primarily responsible for the development and implementation of methods and procedures for process control, process improvement, testing and inspection to ensure that the products continue to meet design and product specifications. This role also performs statistical analysis to maintain quality levels and minimize defects and failure rates, including on-going review of Quality Control testing for material release and resulting data to determine trends and recommend corrective actions. The Process Quality Engineer coordinates activities of the Material Review Board (MRB) and ensures appropriate material dispositions. The role collaborates as necessary, with operational stakeholders on quality problems, ensures that effective corrective actions are implemented and contributes to Operations Quality improvement programs. Job Responsibilities Work closely with operations and the business functions to ensure quality performance of product and processes. Collaborates with Divisional QA, cross-functional groups, and supplier teams to address quality issues. Support implementation and/or verification of material and/or equipment specifications. Reviews incoming inventory material receiving records, and quality control testing documentation to release the materials for production use Accountable for Material and Product releases through review and release of kit manufacturing and batch manufacturing records Support execution of PFMEA, DFMEA and SOP generation associated with design transfers and product launch Support execution and analysis of manufacturing related complaints and product field actions. Execute internal quality deliverables associated with operational changes, manufacturing transfers and supplier-initiated changes. Participates and may lead change control management; creation and/or review of new or modified procedures. Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating appropriate actions as necessary. Own or support identified internal NCs, Deviations, Quality events, CAPAs, and manage to timely root cause investigation, implementation and closure. Work to introduce and implement Six sigma, process improvement, statistical and problem-solving tools and methodologies Support the development and review of production processes and for feedback through Measurement System Analysis (MSA) using DMAIC and tools. Applies statistical methods of analysis and process control to current operations. Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations. Responsible for initiation, internal containment, communication, and support of Commercial Holds for potential product escapes. Ensure adherence to GMP and safety procedures. Required Qualifications Bachelor's degree in engineering/science or related discipline with 2+ years' experience in a regulated environment OR High School diploma with 5+ years of experience in a regulated environment. Demonstrated knowledge of quality assurance principles. Demonstrated knowledge of improvement and statistical tools/methods used within process excellence activities. Good knowledge of quality control and monitoring methodologies. Experience in executing problem solving techniques related to manufacturing/design technical issues. Proven ability to drive and develop improvement of critical business metrics. Preferred Qualifications High School Diploma with 8+ years' experience in a regulated environment, or Bachelors degree with 5+ years' experience, or Master's Degree with 2+ years' experience. A minimum of 2 years of experience working within FDA regulated (Medical Device, Pharmaceutical) highly preferred and/or regulated industries (Automotive, Aerospace) preferred. Experience in change management, as well as ensuring assets are appropriately addressed to remain in a validated state. A Green Belt Certification in Six Sigma or similar certification preferred. Demonstrated organizational, interpersonal, oral and written skills. Physical Demands Employee may be required to lift routine office supplies and use standard office equipment. Ability to sit for extended periods of time. Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment. Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other This position requires some evenings, weekends and/or Holidays. Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.