Supplier Quality Engineer jobs at GE Healthcare Information Technologies

- 344 jobs

Sr. Quality Outcomes Specialist/RN - Willowbrook
Houston Methodist Willowbrook Hospital 4.5
Houston, TX jobs
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.
$65k-88k yearly est. 1d ago
Process Engineer
Piping Rock Health Products 4.1
Aurora, OH jobs
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.
$61k-79k yearly est. 3d ago
Supplier Quality Engineer
Philips Healthcare 4.7
Murrysville, PA jobs
Job TitleSupplier Quality EngineerJob Description The Supplier Quality Engineer is a key member of Philips' Sleep & Respiratory Care Quality team, responsible for driving supplier partners' high-quality performance by applying Advanced Product Quality Planning (APQP) in product industrialization, striving for continuous quality improvement throughout the product lifecycle, and ensuring regulatory compliance. Your role: Facilitates technical capability assessments of potential new suppliers, and collaboration between R&D and suppliers in Design for Excellence (DfX) initiatives to enhance product design quality and innovation. Conducts & reviews Design for Manufacturing and Assembly Technique (DFMAT), Supplier Approval Form (SAF), Measurement System Analysis (MSA), PFMEA, Control Plans, SPC, Process V&V, FAI, Logistics Risk Assessment (LRA), and Supplier Initiated Change Request (SICR). Develops, executes, monitors, and controls APQP (Advanced Product Quality Planning) plans as part of the NPI process to ensure consistent product quality. Focuses that Critical to Quality (CtQ) characteristics are effectively communicated to suppliers and rigorously maintained throughout the production process. Coordinates Part Submission Warrant plans, deliverables, line releases, and completion, ensuring all parts meet specified quality standards before approval. Executes supplier improvement and development initiatives on APQP (Advanced Product Quality Planning), providing guidance and resources to enhance supplier processes, ensuring they meet the high standards required for production quality and efficiency. Assists with the process of making additions, changes, or deletions to the Approved Supplier List, ensuring that only qualified suppliers are retained. Supports in end-to-end performance management of suppliers, conducts detailed analysis of defects to determine if they are supplier-caused, and acts as an independent reviewer for SCAR's. You're the right fit if: You have a minimum of 5+ years' experience in Supplier Quality Engineering within highly regulated product environments (Medical Device preferred), with a focus on supplier selection, performance assessment, APQP, Risk Assessments/PFMEA's, SPC, SCAR's, SICR, CAPA, Remediation etc. You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282). You have proven experience utilizing data analytics/KPI's to assess supplier performance and identify/drive process improvement opportunities. You have strong communications skills and the proven ability to effectively communicate, influence and build relationships cross-functionally with a variety of internal/external stakeholders, suppliers, Regulatory Agencies, Notified Bodies etc. You have a minimum of a Bachelor's Degree (Required) in Quality, Engineering, or related disciplines. ASQ and/or Six Sigma DfX Certifications- Desired. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details: The pay range for this position in Murrysville, PA is $87,000 to $139,200 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. 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. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. Additional Information: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Murrysville, PA . This role may require travel up to 10%. #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.
$87k-139.2k yearly Auto-Apply 60d+ ago
Senior Product Quality Engineer
Hologic 4.4
Marlborough, MA jobs
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
$97.6k-152.7k yearly 43d ago
Senior Product Quality Engineer
Hologic 4.4
Marlborough, MA jobs
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
$97.6k-152.7k yearly Auto-Apply 43d ago
Senior Product Quality Engineer
Hologic 4.4
Marlborough, MA jobs
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
$97.6k-152.7k yearly Auto-Apply 1d ago
Supplier Quality and Development Engineer
GE Healthcare 4.8
Madison, WI jobs
As a Supplier Quality Lead Engineer, you will drive quality for assigned suppliers, implement quality plans, drive improvements utilizing supplier scorecards, select suppliers through qualification processes and own supplier audits and results. You will be responsible to execute Part Quality Plans and site wide initiatives. You will also lead broad projects spanning multiple suppliers with high business impact. This will be an individual contributor role with leadership in multiple projects in supply base and production GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Roles and Responsibilities:** + Lead on technical projects and process improvement initiatives. + Responsible for both Supplier Quality Assurance and Supplier Quality Development, including supplier qualifications, action plans, audits, performance monitoring, and assisting key suppliers towards industrial standards of excellence. + Work with internal and external stakeholders to drive increased quality standards. + Requires strong communication skills while partnering with global stakeholders both internally and externally. + Resolve issues in situations that require good knowledge and judgment within established procedures using quality engineering methodology like root cause investigation and part qualification. **Required Qualifications:** + Bachelor's degree from an accredited university or college. + Minimum of 4 years industry experience in Manufacturing, Quality, Engineering, Supplier Quality or related fields. + Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening. **Desired Characteristics:** + Electronics, Circuit Boards manufacturing, or Cable and Harness experience is strongly preferred + Experience in Plastics, Fabrication and Machining. + Strong project management skills. + Experience with PPAP, part qualification, CAPA. + New Product Launch experience. + Industry experience in manufacturing engineering, R&D, and quality. + ASQ or AIAG Certified. + Masters degree in Engineering or other technical disciplines. We will not sponsor individuals for employment visas, now or in the future, for this job opening. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** Yes
$69k-85k yearly est. 36d ago
Supplier Quality and Development Engineer
GE Healthcare 4.8
Madison, WI jobs
SummaryAs a Supplier Quality Lead Engineer, you will drive quality for assigned suppliers, implement quality plans, drive improvements utilizing supplier scorecards, select suppliers through qualification processes and own supplier audits and results. You will be responsible to execute Part Quality Plans and site wide initiatives. You will also lead broad projects spanning multiple suppliers with high business impact. This will be an individual contributor role with leadership in multiple projects in supply base and production GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionRoles and Responsibilities: Lead on technical projects and process improvement initiatives. Responsible for both Supplier Quality Assurance and Supplier Quality Development, including supplier qualifications, action plans, audits, performance monitoring, and assisting key suppliers towards industrial standards of excellence. Work with internal and external stakeholders to drive increased quality standards. Requires strong communication skills while partnering with global stakeholders both internally and externally. Resolve issues in situations that require good knowledge and judgment within established procedures using quality engineering methodology like root cause investigation and part qualification. Required Qualifications: Bachelor's degree from an accredited university or college. Minimum of 4 years industry experience in Manufacturing, Quality, Engineering, Supplier Quality or related fields. Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening. Desired Characteristics: Electronics, Circuit Boards manufacturing, or Cable and Harness experience is strongly preferred Experience in Plastics, Fabrication and Machining. Strong project management skills. Experience with PPAP, part qualification, CAPA. New Product Launch experience. Industry experience in manufacturing engineering, R&D, and quality. ASQ or AIAG Certified. Masters degree in Engineering or other technical disciplines. We will not sponsor individuals for employment visas, now or in the future, for this job opening. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: Yes
$69k-85k yearly est. Auto-Apply 21d ago
Supplier Quality Engineer (Onsite - Acton, MA)
Insulet Corporation 4.7
Acton, MA jobs
Supports the selection, qualification, and management of external suppliers to lnsulet. Closely works with manufacturers and service suppliers to ensure product/service quality meets lnsulet requirements. Interfaces with other Insulet departments (e.g. Operations, Supply Chain, and Regulatory Affairs) as well as with suppliers and other external parties on qualification efforts and issues related to product quality. Effectively communicates Quality metrics through Supplier Management Review to the organization, suppliers, and Executive Management. Responsibilities: Maintain approved supplier list and supplier history records in accordance with quality system requirements. Assist with the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications. Maintains accuracy of Supplier Audit Reports and Supplier Profile Plans and conducts scheduled audits of suppliers to assess compliance with lnsulet Requirements. Prepares detailed trip reports and Audit Reports to document audit findings and observations Communicates quality issues to suppliers as needed and aids development of corrective actions Initiate and follow up on supplier corrective actions for both audit deficiencies and internal non-conformances to ensure timely closure. Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility Tracks and trends supplier performance, taking remedial action as needed Conduct and assist with internal audits Assist or leads CAPA evaluation and closure as related to the supplier quality processes and or supplier performance. Participate in developmental and departmental training Support Site during external audits (i.e. BSI, FDA, Customer). Performs other duties as required Education and Experience: BS/BA Degree or Equivalent 2 to 4 years of experience in quality in the medical device industry Medical device or related industry experience in a technical position Working knowledge of the Quality System Regulation (FDA 21CFR Part 820) and ISO 13485 quality system standards Auditor training certification to ISO 13485, 17025 or other industry QMS Standard preferred CQE and / or CQA certification is desirable Skills/Competencies: Strong verbal and written communication skills, internal and external to the company. Good interpersonal skills in dealing with suppliers, peers and other functional areas. The ability to prioritize multiple competing deliverables simultaneously. Must be proficient in Word, Excel, Outlook and Power Point. Ability to lift up to 20 pounds Physical Requirements: International and Domestic travel required, up to 50%. NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $68,700.00 - $103,050.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)
$68.7k-103.1k yearly Auto-Apply 25d ago
Supplier Quality Manager
Diasorin 4.5
Austin, TX jobs
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist." Why Join Diasorin? * Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world. * Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry. Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive. Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact! Job Scope The Supplier Quality Manager is responsible for developing and managing the supplier quality program within an in vitro diagnostics (IVD) manufacturing environment. This role ensures that suppliers of raw materials, components, and services meet applicable regulatory requirements (FDA 21 CFR Part 820, ISO 13485, IVDR) and company quality standards. The Supplier Quality Manager partners with Procurement, Manufacturing, R&D, and Regulatory Affairs to drive supplier qualification, audits, continuous improvement, and compliance. Duties and Responsibilities * Develop, implement, and maintain the supplier quality management program. * Manage and conduct supplier audits in accordance with FDA, ISO 13485, MDSAP, and IVDR requirements. * Qualify and approve new suppliers, materials, and services for use in IVD manufacturing. * Manage supplier corrective actions (SCARs) and ensure timely resolution of quality issues. * Assign and Manae Supplier Quality Scorecard assessments * Collaborate with Procurement and R&D during supplier selection and qualification. * Review and approve supplier change notifications. * Monitor supplier performance metrics and drive continuous improvement initiatives. * Ensure supplier compliance with product, regulatory, and contractual requirements. * Act as SME during regulatory inspections for supplier management topics. * Manages Regular Supplier Review Board Meetings (global) * Lead risk assessments for suppliers and support overall supply chain risk management. * Other duties as assigned Knowledge, Experience and Qualifications * Bachelor's degree in Engineering, Life Sciences, or related field required. * Master's degree preferred. * 7+ years of experience in Quality Assurance within IVD or medical device manufacturing. * 3+ years of experience in supplier quality management or related role. * Proven experience leading audits (internal and external). * Experience with FDA 21 CFR 820, ISO 13485, IVDR, and ISO 14971 risk management. Training, Skills and Certifications * Strong knowledge of supplier quality principles, auditing, and risk management. * Thorough knowledge of FDA regulations and cGMP guidelines. ISO 13485, IVDR. * Excellent problem-solving and root cause analysis skills. * Highly organized with proven time-management skills * Strong communication and negotiation skills with suppliers and internal teams. * Proficiency with electronic Quality Management Systems (eQMS). * ASQ certifications (CQA, CQE, or equivalent) preferred. Travel Requirements * 25% Travel may be required * 5% International travel may be required Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at ********************* or ************** to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department. Nearest Major Market: Austin
$79k-100k yearly est. 9d ago
Supplier Quality Engineer
Carislifesciences 4.4
Phoenix, AZ jobs
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.
$77k-104k yearly est. Auto-Apply 13d ago
Supplier Quality Engineer
Air Techniques 3.8
Melville, NY jobs
, Inc. Founded in 1962, Air Techniques, Inc. set out to manufacture first-rate products for the dental industry. Over 63 years later, Air Techniques has grown from a small company into a successful corporation. At our New York headquarters, we design and build two main groups of products: utility room and digital imaging products. Our products are manufactured in a vertically integrated factory where compliance with the Food and Drug Administration Good Manufacturing Practices is paired with stringent Quality Standards. In-house engineering staff designs our products for the dental market. We are proud to maintain the ISO-13485 registration certification which reinforces our pledge to quality and customer satisfaction. At Air Techniques, we have earned our reputation in the dental industry through our commitment to quality and ensuring customer satisfaction. We are proud that Air Techniques represents superior quality to dealers and dentists worldwide. Position Description The Supplier Quality Engineer ensures supplier compliance with regulatory standards through audits, monitoring, and on-site root cause analysis. They implement corrective actions, track supplier quality metrics, and lead initiatives to improve the Quality Management System. This role involves reviewing customer complaints, conducting product investigations, and handling medical device reporting assessments. The ideal candidate has experience in supplier management and FDA-regulated industries, particularly in medical devices, with proficiency in relevant regulations and standards. Strong communication, teamwork, and problem-solving skills are essential. This position is based on site at our Melville, New York facility. Primary Responsibilities Perform regular supplier audits to ensure regulatory compliance Monitor and improve supplier quality and process performance Facilitate and perform on-site visits for root cause analysis Implement and verify corrective actions of supplier quality issues Create, monitor, and present supplier quality performance metrics Maintain accurate quality records for supplier management Develop new approaches to solve problems identified during quality assurance activities. Assists or leads activities/projects to improve the Quality Management System including coordinating, development, training and maintenance Review customer complaints, conduct product investigations, and ensure proper complaint closure Conduct medical device reporting assessments and process potential MDR reports Ideal candidate should possess good problem solving & logical decision-making abilities Develop sampling plans for evaluating, and reporting quality and reliability data Demonstrate continuous effort to improve product quality and manufacturing processes 5-7 years in manufacturing industry in Quality functions in an FDA regulated or equivalent industry. Experience in medical device industry highly desirable. Experience in Supplier Management Working knowledge of FDA regulations, cGMP, US-FDA's 21 cfr part 820, and ISO 13485:2016 Strong MS office skills Excellent communication, interpersonal skills, teamwork and problem solving skills Travel approximately 30% Education Requirements Bachelors degree in Engineering preferred It is the policy of Air Techniques to provide equal employment opportunities to all qualified applicants without discrimination on the basis of race, creed, color, religion, national origin or ancestry, gender, citizenship, age, disability, marital status, veteran status, sexual preference, or any other characteristic protected by applicable federal, state, or local laws.
$69k-90k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer
Conformis Inc. 4.3
Wilmington, MA jobs
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
$83k-107k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer II
Conformis Inc. 4.3
Wilmington, MA jobs
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
$83k-107k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer
Conformis Inc. 4.3
Wilmington, MA jobs
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
$83k-107k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer
Conformis Inc. 4.3
Wilmington, MA jobs
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
$83k-107k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer
Conformis Inc. 4.3
Wilmington, MA jobs
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
$83k-107k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer II
Conformis Inc. 4.3
Wilmington, MA jobs
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
$83k-107k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer II
Conformis Inc. 4.3
Wilmington, MA jobs
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
$83k-107k yearly est. Auto-Apply 60d+ ago
Process Quality Engineer
Carislifesciences 4.4
Phoenix, AZ jobs
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.
$67k-86k yearly est. Auto-Apply 13d ago