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Supplier Quality Engineer jobs at Abbott - 854 jobs

  • Quality Engineer

    Abbott 4.7company rating

    Supplier quality engineer job at Abbott

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: MAIN PURPOSE OF THE ROLE Provide Process/Quality Engineering and Quality Systems support to distribution activities, helping to ensure delivery of highest quality product to the customer. MAIN RESPONSIBILITIES Support QMS Implementation and maintenance of applicable distribution sites. Activities include documentation updates, new releases of documents, QMS reviews for audit preparation, participation in internal and external agency audits Reduces and controls distribution process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. Execute qualification/validation activities to support distribution projects and internal process implementation driven by the business units. Own and execute improvement activities (CAPA/NCMR), performing root cause analysis, implementation of solutions to mitigate risk. Analyze complex interdisciplinary problems and identifies their impact, establishes probabilities, draws conclusions reflecting broad business needs, understands organizational and financial impact of recommendations, (e.g.,applies regulatory requirements and recommends best course of action). Responsible for product stops ship execution (containment, releases, disposition executions (scrap, rework, sort). Develops and implements quality plans, documents and systems by creatingquality specifications, risk analyses, FMEAs in conjunction with other cross functional teams Responsible for risk analyses and FMEAs of distribution processes. Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of distribution defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects. Collects and analyzes process defect data (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development. Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. Interact with business units/mfg site to support product flow or dispositions through distribution Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. (Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources. QUALIFICATIONS Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact. Minimum 5 years preferred Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships. Strong verbal communications to work with highly matrixed organization. Quality System experience related to implementation and/or maintenance of quality management systems for effectiveness. Education Education Level Major/Field of Study or Equivalent Associates Degree (± 13 years) Experience/Background Experience Experience Details Minimum 4 years The base pay for this position is $75,300.00 - $150,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations QualityDIVISION:EP ElectrophysiologyLOCATION:United States > Avon : 10207 Veterans DriveADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:NoMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Work in a clean room environment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
    $75.3k-150.7k yearly Auto-Apply 60d+ ago
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  • 300k Base Salary + Quality Bonuses in Beautiful Kansas

    The Curare Group 3.7company rating

    Pueblo, CO jobs

    Family Medicine provider needed in Kansas. Enjoy the charm of small-town living with a strong sense of community and excellent healthcare facilities. Known for its welcoming atmosphere, the area boasts top-rated schools, affordable housing, and abundant outdoor activities, including parks and nearby lakes. With a thriving local economy and family-friendly environment, it's an ideal place to work and call home. Practice details include: Hospital Employee 1:4 Call Ratio $290-300K Annual Salary WRVU production incentives Signing Bonus available, contact us for details Relocation Bonus available CME time available
    $82k-119k yearly est. 8d ago
  • Supplier Quality Engineer

    Philips Healthcare 4.7company rating

    Plymouth, MN jobs

    Job TitleSupplier Quality EngineerJob Description Supplier Quality Engineer In this role you You are responsible for ensuring superior quality performance at supplier partners. Proactively manage, monitor, and troubleshoot supplier-related issues. Your role: Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process. Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies including monitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring. Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary. Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations. Assuring technical quality of suppliers, manufacturers, and OEMs is maintained and acceptance criteria are in alignment with component/product use and customer expectations. You're the right fit if: Bachelor's degree in engineering science: Electrical Engineering, Mechanical Engineering, or equivalent. Prefer 3+ years of experience in Supplier Quality, Supplier Evaluation, Data Analysis, DFX Methodology, Process Validation, Continuous Improvement. Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. How we work together We believe that we are better together than apart. 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 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 Plymouth MN is $60,750 to $85,000 Annually. 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 Plymouth, MN. #LI-PHI 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.
    $60.8k-85k yearly Auto-Apply 19d ago
  • Advanced Product Quality Engineer

    Health & Home USA 3.4company rating

    Marlborough, MA jobs

    Our Beauty & Wellness division empowers consumers with trusted products that support self-care, from salon-quality styling tools to wellness devices like humidifiers and air purifiers. Our innovative products and solutions promote healthy living, elevating the lives of consumers every day. This business unit includes Braun, PUR, Honeywell, Vicks, Hot Tools, Drybar, Curlsmith, and Revlon brands, and this role may support one or more of these brands. Look around your home, and you'll find us everywhere, in your kitchen, living room, bedroom, and bathroom. We are already making your everyday lives better. We are powered by knowledgeable, enthusiastic, and forward-thinking people committed to developing a culture of inclusion. Whether you are just starting your career or in need of a challenge, we recognize, develop, and empower talent! Position: Advanced Product Quality Engineer Department: Engineering - Beauty & Wellness Work Location: Marlborough, MA, Hybrid (work 3 days onsite) Hybrid Schedule: At Helen of Troy, we embrace a flexible hybrid work model designed to support collaboration and productivity. For roles eligible for hybrid work, our standard schedule includes in-office collaboration from Tuesday through Thursday, with the option to work remotely on Mondays and Fridays. Any updates to this model will be communicated in advance. Please note that hybrid eligibility and schedules may vary based on business needs and manager expectations. What you will be doing: As Advanced Quality Engineer, you will serve as the quality lead who will collaborate with new product development teams to capture consumer feedback and ensure built-in quality in our next generation of Beauty and Wellness products. You will also be supporting continuous improvement teams to drive down field return rates by working on quality improvement initiatives and provide technical expertise to solve complex problems. Reduce return rate and ensure 4.5+ online star rating by ensuring quality deliverables are fulfilled as part of the new product development process and launch products that meet consumer expectations. Create lessons learned document which includes a list of quality issues to be addressed by analyzing all available sources of data to develop an expert understanding of consumer needs from both a functionality and a usability perspective and work with product design teams to come up with engineering solutions on key quality issues on similar products and competitor products. Develop design qualification test plans in collaboration with engineering team that are representative of consumer use cases. Define critical to quality (CTQ) characteristics in product & manufacturing specification. Create risk management documents (DFMEA, Hazard analysis, Risk management plan and Risk management reports). Ensure product quality and safety risks are mitigated in a timely manner before launch. Perform product teardowns of engineering build samples to critically evaluate the design and provide inputs in design reviews. Review manufacturing quality control plans (IQCP, IPCP) and work closely with contract manufacturing vendors to ensure robust assembly processes. Review manufacturing readiness review checklist to verify all risks are mitigated and the product is ready for mass production. Make technical recommendations to drive improvements by identifying, analyzing, and interpreting quality trends. Work closely with engineering & supplier quality teams and manufacturing vendors in identifying root causes and corrective actions. Lead periodic quality review meetings with cross-functional teams and follow up on identified improvement initiatives to drive cost of quality improvements. Review and approve engineering change orders and document change orders. Co-ordinate with cross functional teams to resolve ad-hoc customer issues and field quality issues and maintain timely and effective communication with management teams on risks and status. 10-15% travel may be required (international and domestic) Perform other tasks as needed. Skills needed to be successful in this role: Must possess effective problem solving, root cause analytical skills, and have the ability to lead and influence others to drive change. Strong leadership in execution of all phases of new product development Ensure all projects, initiatives, and processes are in conformance with established policies and objectives. Demonstrated abilities with small appliance design, manufacturing and other practices including plastic design, molding, and electrical appliances. Pro-active attitude, leadership, project management and teamwork skills needed to interact with a cross-functional global team and direct them in achieving assigned goals and objectives. Ability to handle multiple projects and remain flexible and adaptable. Strong communication and presentation skills including the ability to provide concise and accurate status of projects on a periodic basis. Demonstrated troubleshooting ability to identify issues, assess technical and project alternatives and risks, and implement solutions while keeping the projects on track. Strong understanding of root cause analysis methods and ability to lead cross-functional team to find feasible solutions to complex technical issues. Minimum Qualifications: Bachelor of Science Degree in Mechanical, Industrial, or Electrical engineering. 5+ years of hands-on experience working in a product quality engineering role with a high-volume consumer products, small appliances, or household appliances manufacturing company. Quality Engineering background with experience in statistical data analysis. Proficient in advanced excel skills. Experience in statistical analysis software like Minitab. Authorized to work in the United States on a full-time basis Preferred Qualifications: ASQ certifications - CQE, CRE, Six Sigma Green Belt/Black Belt certification Masters degree. In Massachusetts, the standard base pay range for this role is $82,000 - $100,000 annually. This base pay range is specific to Massachusetts and may not be applicable to other locations. Actual salaries will vary based on several factors, including but not limited to location, experience, skill level, and performance. The range listed is just one component of the total compensation package for employees. Benefits: Salary + Bonus, Healthcare, Dental, Vision, Paid Holidays, Paid Parental Leave, 401(k) with company match, Basic Life Insurance, Short Term Disability (STD), Long Term Disability (LTD), Paid Time Off (PTO), Paid Charitable (volunteer) Leave, and Educational Assistance. Wondering if you should apply? Helen of Troy welcomes people as diverse as our brands! Have the confidence to come as who you are because your point of view, skills, and experience will make us stronger. If you're eager to share new ideas and try new things, we want to hear from you. #li-ab1 #LI-HYBRID For more information about Helen of Troy, visit ******************** You can also find us on LinkedIn, and Glassdoor. Helen of Troy is an Equal Opportunity/Affirmative Action Employer. We are committed to developing a diverse workforce and cultivating an inclusive environment. We value diversity and believe that we are strengthened by the differences in our experiences, thoughts, cultures, and backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. We will provide individuals with disabilities with reasonable accommodations to participate in the job application process. If you would like to request an accommodation, please contact Human Resources at **************. Founded in 1968, Helen of Troy is a prominent player in the global consumer products industry, offering diverse career opportunities across North America, South America, Europe, and Asia. We boast a collection of renowned brands such as OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar, Curlsmith, Revlon, and Olive & June - many of which rank #1, #2, or #3 in their respective categories, making the Helen of Troy name synonymous with excellence and ingenuity. At Helen of Troy, our strategy involves acquiring brands that we can integrate and enhance, amplifying their unique attributes to drive growth and profitability. Embracing a culture of collaboration internally and externally, we are committed to providing innovative solutions tailored to consumers, operational excellence, global scalability, and exceptional shared services to support our brand portfolio. This dedication to fostering development and success sets Helen of Troy apart as a pioneer in the industry, propelling our brands to unparalleled heights of success and recognition worldwide. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time.
    $82k-100k yearly Auto-Apply 19d ago
  • Principal Supplier Quality Engineer

    Avanos Medical 4.2company rating

    Georgia jobs

    Job Title: Principal Supplier Quality Engineer Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit *************** Essential Duties and Responsibilities: Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures.This position provides technical leadership for Supplier Quality Management processes and activities. The primary purpose of this position is to implement, coordinate, support, and monitor activities related to the Global Supplier Quality Management (SQM) activities across Avanos. This position may also train R&D, Technical Quality, Operations, and other functions on the established processes and any enhancements as needed and perform other additional duties as assigned.. Key Responsibilities: Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices to ensure the manufacturing and distribution of products comply with applicable regulatory requirements. Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers. Establish and administer the supplier audit program for quality/regulatory compliance. Maintain the Approved Supplier List (ASL). Support the Global Supplier Review Board, including providing metrics for supplier assessments. Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits. Provide guidance as needed for corrective action required because of assessment findings. Execute supplier audits in accordance with approved schedules. Support documentation of supplier changes through the supplier notification, change management, QNC, or CAPA processes. Contribute to the supplier qualification vetting process and perform supplier evaluations to ensure appropriate suppliers are being selected. Continuously improve existing Supplier Quality Management Process to ensure compliance with regulatory requirements. Develop, implement, and execute a system for conducting due diligence evaluations for supplier qualifications and acquisitions. Provide auditing support during due diligence and integration activities as needed. External Interface: This role will primary interface externally with suppliers and with external auditors from Notify Bodies and Regulatory Agencies Your qualifications Required: Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience. Preferred: B.S. in Engineering, Science, Business, or another relevant field Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry. Supplier Quality Engineering experience in the Medical Device industry Strong understanding of Risk Management principles and techniques. Knowledge of Statistical Techniques Experience in root cause analysis and failure investigation tools Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc. Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor Strong project management skills Ability to make reasonable decisions and be able to effectively justify them Strong collaborative skills and customer service approach Exceptional written, verbal, and presentation communication skills The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position. Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. IMPORTANT: If you are a current employee of Avanos or a current Avanos Contractor, please apply here. Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world. Make your career count Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. Avanos also offers the following: benefits on day 1 free onsite gym onsite cafeteria HQ region voted 'best place to live' by USA Today uncapped sales commissions
    $66k-76k yearly est. 50d ago
  • Senior Product Quality Engineer

    Hologic 4.4company rating

    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 60d+ ago
  • Senior Product Quality Engineer

    Hologic 4.4company rating

    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 60d+ ago
  • Senior Product Quality Engineer

    Hologic 4.4company rating

    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 60d+ ago
  • Product Quality Engineer II

    Hologic 4.4company rating

    Marlborough, MA jobs

    Newark, DE, United States Marlborough, MA, United States Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a **Product Quality Engineer 2** to provide engineering support for on-market medical devices. In this role, you'll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you'll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you're a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation. **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP. + Familiarity with root cause analysis tools, risk management principles, and compliance frameworks. + Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility. **Skills:** + Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues. + Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations. + Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership. + Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained. + Proficiency in developing or improving testing methods for complaint investigations and technical activities. + Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements. + Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications. **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, driving process optimization and identifying opportunities to enhance product quality. **Experience:** + Bachelor's degree in Engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required. + **2-5 years** of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry. + Hands-on experience in complaint investigations, root cause analysis, and CAPA activities. + Familiarity with internal and external audits, including Notified Body and FDA inspections. **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 $78,000-$122,100 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
    $78k-122.1k yearly 19d ago
  • Supplier Quality Engineer

    Carislifesciences 4.4company rating

    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 8d ago
  • Supplier Quality Engineer

    Air Techniques 3.8company rating

    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
  • Sr. Product Quality Engineer

    Noah Homes 4.1company rating

    San Carlos, CA jobs

    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.
    $120.6k-150.8k yearly Auto-Apply 60d+ ago
  • Product Quality Engineer II

    Conformis Inc. 4.3company rating

    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
  • Product Quality Engineer

    Conformis Inc. 4.3company rating

    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

    Conformis Inc. 4.3company rating

    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 II

    Conformis Inc. 4.3company rating

    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. 4.3company rating

    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

    CEL 3.2company rating

    Williamsburg, VA jobs

    CEL Critical Power - Powering the AI Revolution: CEL has an opportunity for you to join our rapidly growing US business, where you will have an opportunity to make a significant impact on our immediate and long-term success of our Supply Chain function. CEL is an Irish based 40-year manufacturer, distributor and exporter of electrical switchgear and controls, and related products and services, now focused on the supplying the global Data Centre industry. Operating from our newly acquired 400,000ft2 facility in Williamsburg, Virginia, we aim to double in size each year for the next three years. CEL is led by a hard-working team who follow traditional working practices, value collaboration, continuous improvement, excellence in quality and commercial curiosity; this is your chance to develop your career as part of a dynamic US SMT who will shape the future of our business. We strongly believe that seeking out and hiring the most diverse talent and creating an inclusive workplace is the way to create an exceptional and innovative workplace for our employees which will deliver excellence in service to our customers. We encourage applications from people with diverse backgrounds and experience to join this multicultural, hard-working team. About The Role: Reporting to the Quality Manager, we are seeking a highly driven Product Quality Engineer to ensure that our assembly process consistently delivers finished products that meet stringent electrical, mechanical and regulatory requirements. You will be responsible for ensuring that all manufacturing processes and products perform on a consistent basis to meet CEL's quality standards and customer requirements. This role focuses on process development and control, defect prevention and continuous improvement in a complex manufacturing environment. The ideal candidate will have strong attention to detail, experience with electrical / mechanical components and a commitment to continuous improvement. What You'll Be Doing: Quality Assurance in Manufacturing: Develop and maintain quality control plans for production processes. Monitor and audit manufacturing operations to ensure compliance with product specifications. Investigate and resolve quality issues, including root cause analysis, corrective and preventive actions. Verify the effectiveness of permanent corrective actions over time to ensure there is no recurrence. Process Improvement: Identify opportunities to reduce defects and improve process capability. Implement Lean and Six Sigma methodologies to enhance quality performance. Support continuous improvement projects across production lines. Customer & Compliance Requirements: Ensure products meet UL and other relevant electrical standards. Manage documentation for quality compliance and certifications. Liaise with customers on quality-related concerns and provide technical support. Data Analysis & Reporting: Track and report key quality metrics e.g. 1st Pass yield, scrap rate, and defect rates. Prepare monthly quality performance reports for management. Use statistical tools to analyse trends and predict potential issues. Cross-Functional Collaboration: Work closely with engineering, production and supply chain teams. Support new product introduction with quality planning and validation. Train operators and staff on quality standards and best practices. Requirements Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, or related). +5 years of Quality Engineering in a manufacturing environment. Six Sigma Green / Black Belt or equivalent certification. Strong understanding of electrical / mechanical components and assemblies. Experience with internal audits, PPAP, FMEA, control plans and statistical process control. Proficiency in root cause analysis tools (8D, Ishikawa, 5 Whys). Ability to interpret engineering drawings and electrical schematics. Excellent communication and supplier-facing negotiation skills. Benefits Competitive salary and performance-based incentives Health, dental, and vision insurance 401(k) retirement plan Paid time off and holidays Professional development and career advancement opportunities A dynamic and growing team focused on innovation and excellence
    $85k-108k yearly est. Auto-Apply 41d ago
  • Process Quality Engineer (Onsite in Latham, New York)

    Philips Healthcare 4.7company rating

    New York jobs

    Job TitleProcess Quality Engineer (Onsite in Latham, New York) Job Description Process Quality Engineer (Onsite- Latham, NY) The Process Quality Engineer at Latham ensures facility and product compliance with ISO 13485 and all relevant regulations, standards, and procedures. They also verify products meet requirements before distribution and lead ongoing quality and process improvements. Your role: The Process Quality Engineer (QE) is a member of the Operations Quality team in Latham and works closely with Area Managers, Team/Group Leads and Manufacturing Engineers (MEs) to optimize production within an area by creating and executing accurate and effective documentation compliant with GDP, documenting and tracking nonconformances, supporting problem-solving and continuous improvement activities, and maintaining documentation verifying effective On the Job Training (OJT) of operators. Ensures that executed processes meet the requirements of the site's QMS, including but not limited to: the creation of Quality Data Sheets (Data Collects), change control, deviations, nonconformances, PFMEAs/control plans, Device History Records (DHRs) and Corrective and Preventive Actions (CAPAs). This position reports into the Latham Operations Quality Manager. The employee will work closely with the Operations team responsible for his/her area of oversight, while aligning with the Operations Quality team to ensure compliance, consistency and efficiency throughout the organization. This employee will have the opportunity to work closely with other Quality, Manufacturing and Design Engineers on a site that has led innovation in the design of magnets for Magnetic Resonance Imaging (MRI) systems. This position requires the employee to be onsite five days per week. You're the right fit if: You've acquired 2+ years of related Quality Engineering experience in the medical device industry preferred, or other regulated industries required (aerospace, defense, automotive, etc.) . You have strong experience with and understanding of ISO 13485 preferred. The ideal candidate will be a change agent and have experience with transformational or change management roles in similar environments previously. Your skills include strong process and manufacturing equipment validation experience, PFMEA's, control plans, and working with statistical analyses tools. Strong ability to support Nonconformances, CAPA's, process documentation, Measurement System Analysis, Test Method Validations, and Design History Review, among other things is required. You have a bachelor's degree or higher in Mechanical Engineering, Electronics Engineering, Science or equivalent. Lean Six Sigma certification preferred but not required. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You're an excellent communicator with an ability to work well cross functionally, and adapt to changing priorities. Requires up to 10% travel as required by business needs. How we work together We believe that we are better together than apart. 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 onsite role, requiring five days per week onsite in Latham. 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 Latham, NY 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. 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 Latham, NY. #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 5d ago
  • Process Quality Engineer

    Carislifesciences 4.4company rating

    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 41d ago

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