Quality Engineer jobs at Medline - 2056 jobs

Location: Wayne, NJ, US; Providence, RI, US; Boston, MA, US; Philadelphia, PA, US; Hartford, CT, US; Charlotte, NC, US Remote Work: This position is fully remote and requires travel of up to 25% and may include international travel. Salary Range: $112k - $120k with 10% bonus depending on overall With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life‑saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Senior Quality Systems Engineer independently provides hands‑on subject‑matter expertise to support continuous improvement of the Getinge Quality Management System (GetQMS). This role leads creation, enhancement, and maintenance of various QMS documents. Additionally, the role facilitates Quality forums such as the Document Control Community of Practice, Change Review Board, etc. to drive alignment across QMS. This position also collaborates closely with IT and other stakeholders to maintain and improve electronic Document Management System (eDMS) performance, and provides support to document control operations. The position ensures sustained compliance with applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and ISO 9001, while maintaining key quality system infrastructure and records. Job Responsibilities and Essential Duties Creates, revises, and maintains Quality Management System (QMS) documents in accordance with internal procedures and applicable regulatory and standard requirements. Leads the Document Control Community of Practice, driving best practices, and continuous improvement of document control processes across the organization. Facilitates the Change Review Board by coordinating change evaluations, impact assessment, and implementation strategy per established change control procedures. Provides overall support and guidance to document users on using electronic Documentation Management System (eDMS), DCR process, etc. Collaborates with IT on troubleshooting eDMS issues as well as identifying and implementing improvement opportunities. Performs periodic reviews of open Quality Plans and provides status updates when needed. Assists with creating and delivering training material. Owns Nonconformances (NCs) and Corrective and Preventive Actions (CAPA) to address QMS deficiencies. Supports internal audits, external audits, and regulatory inspections by preparing documentation, serving as a subject‑matter expert during audits, and supporting responses to audit observations and corrective actions. Assists with other Management Controls related items (e.g., KPIs, Management Reviews, etc.). Required Knowledge, Skills and Abilities A Bachelor's degree in engineering, Science, or other related field is required. ASQ, RAC, Six sigma or other applicable certifications are a plus. A minimum of 5 years' experience in Medical Device Quality Assurance, Quality Systems, Quality Engineering, or related functions. Prior experience in independently applying Medical Device regulations and standards such as, 21 CFR 820, ISO 13485, EU MDR, etc.) Hands‑on experience with electronic Document Management Systems (e.g., M‑Files, MasterControl, Veeva, TrackWise DOC, Documentum, etc.). Must have organizational skills and attention to detail. M ust demonstrate the ability to solve problems. Must possess good communication skills and be able to communicate to all levels of organization. Must have ability to identify technical user issues and troubleshoot basic systems issues.Must demonstrate ability to work independently and manage multiple tasks and priorities. Must demonstrate sound judgment and strong decision‑making skills. Must show initiative for process improvment and ability to work cross functionally to resolve issues.Must demonstrate effective influencing and change management skills. Proficient in using Microsoft Office Products such as Word, Excel, PowerPoint, SharePoint, etc. About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge At Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, Vision and Travel insurance benefits Registered Pension Plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Hybrid Work Arrangements (where applicable) Parental and Caregiver Leave Tuition Reimbursement Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. #J-18808-Ljbffr

A global medical device company is seeking a Senior Quality Systems Engineer for a remote position. The role involves leading the enhancement of Quality Management System documents, driving best practices, and ensuring regulatory compliance. Candidates should have at least 5 years of experience in Quality Assurance with a strong understanding of medical device regulations. Comprehensive benefits package including health insurance and a registered pension plan is offered. #J-18808-Ljbffr

Quality Program Manager RN - Oncology @ Swedish First Hill Full time Day shift Fantastic benefits and compensation package offered by Providence that begin on your first day of employment. Join us, and find out how many ways we offer you the chance to focus on what really matters - our patients. This role is responsible for regulatory compliance and quality standards in accordance with Foundation for the Accreditation of Cellular Therapy (FACT) guidelines. Under the direction of operational and clinical leadership, the Supervisor leads the compliance audits, corrective action process, and other quality and compliance activities designated in the Quality Management Plan and Audit Calendar. Ensures compliance with FACT, CIBMTR, and other applicable agencies by continually engaging agencies around updates, identifying and updating internal SOPs to reflect changes, and coordinating and documenting education to necessary parties. Regularly reviews status of annual competency requirements, identifies avenues to assist in meeting requirements, and notifies participants of any deficiencies throughout the year. Partners with IS, Best Practice, Clinical Transformation, analytics, patient engagement, patient safety, risk management and other teams to coordinate improvements in education, workflow, Epic, and other areas identified by project teams. Will participate in Quality Management Committee meetings/Transplant CPC meetings and collaborate with various clinical departments for planning, coordination, implementation, and monitoring of all quality management activities throughout the service line. Manages the Quality Calendar and performs associated audits. Shares audit results with leadership, proposes and implements corrective action plans. Participates in the design, creation, validation, analysis, and communication of clinical quality data as it related to organizational priorities in partnership with analytics and other relevant teams. Works closely with Data Managers to ensure data integrity and quarterly CPI requirements are met. Supports the evaluation and continual improvement of quality and safety at Swedish, as represented by the quality management system and/or other standardized practices across the enterprise. Uses standardized principles (i.e., document vetting and control) and processes (i.e., internal audits, preventative/corrective action, risk reduction, action planning) as appropriate. Remains current and knowledgeable about regulatory requirements and payor/government programs such as FACT and CIBMTR. References that information to design effective systems and processes and meets or exceeds those standards. Creates project summaries and reports, leads project committees/workgroups, and provides presentations and other communications to local and system-wide groups/teams in partnership with division leadership as needed. Participates thoughtfully and constructively in team meetings. Assists with onboarding of new team members. Maintains minimum 10 hours of cellular therapy education. Providence caregivers are not simply valued - they're invaluable. Join our team at Swedish First Hill and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them. Required Qualifications: Bachelor's Degree Nursing; graduation from an accredited school. Upon hire: Washington Registered Nurse License. Upon request: Driving may be necessary as part of this role. Caregivers are required to comply with all state laws and requirements for driving. Caregivers will be expected to provide proof of driver license and auto insurance upon request. 3 years Direct patient care. Experience with EHRs. Experience developing clinical care policies, procedures and order sets. Preferred Qualifications: Master's Degree Healthcare. 1 year Experience in a supervisory role; delegating nursing responsibilities to licensed and unlicensed personnel within a medical setting (ambulatory or acute). Why Join Providence? Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally and achieving financial security. We take care of you, so you can focus on delivering our mission of improving the health and wellbeing of each patient we serve. About Providence At Providence, our strength lies in Our Promise of “Know me, care for me, ease my way.” Working at our family of organizations means that regardless of your role, we'll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable. Posted are the minimum and the maximum wage rates on the wage range for this position. The successful candidate's placement on the wage range for this position will be determined based upon relevant job experience and other applicable factors. These amounts are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits. Applicants in the Unincorporated County of Los Angeles: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Unincorporated Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Requsition ID: 405697 Company: Swedish Jobs Job Category: Clinical Quality Job Function: Quality/Process Improvements Job Schedule: Full time Job Shift: Day Career Track: Nursing Department: 3901 SFH HEM ONCOLOGY Address: WA Seattle 1221 Madison Work Location: Swedish First Hill 1221 Madison-Seattle Workplace Type: On-site Pay Range: $57.86 - $89.83 The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. PandoLogic. Category:Quality Control, Keywords:Quality Control / Quality Assurance Manager, Location:Bellevue, WA-98005

Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS applications during inspections and explaining compliance. Train management and onboard new users to the system. Ensure Periodic Reviews (PR) are conducted per required frequency and approve PR Reports. Support Quality System Vendor Audits as a Business SME. Support KPI reporting and lead commitment meetings. Manage regular system updates/releases and assess and recommend new features. Ensure key user-related documentation is maintained and kept up-to-date as new functionalities are enabled, created and/ or modified. Investigate, escalated, and resolve issues identified on system. Execute/facilitate regression testing associated with system upgrades/project implementation. Participate in user forums/industry groups to garner best practice and represent Alkermes. Identify opportunities for continuous improvement and prioritize and manage associated change to completion. Qualifications Bachelor's degree in Computer Science, Engineering, or related field and five years of experience implementing and maintaining regulated systems. Experience must include five years each of the following: project management; development of user procedures; and SaaS (Software as a Service Solution)/cloud solutions. Experience must include one year each of the following:TrackWise Digital, ComplianceWire, and Veeva; system testing in a regulated industry; quality systems processes in commercial/clinical pharma/healthcare facility; US FDA, ICH guidelines, and European regulatory requirements; GAMP; and development of CBT (computer-based training) modules. Experience may be gained concurrently. The annual base salary for this position ranges from $141,000 to $146,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website:************************************* . #J-18808-Ljbffr

Quality Program Manager RN - Oncology @ Swedish First Hill Full time Day shift Fantastic benefits and compensation package offered by Providence that begin on your first day of employment. Join us, and find out how many ways we offer you the chance to focus on what really matters - our patients. This role is responsible for regulatory compliance and quality standards in accordance with Foundation for the Accreditation of Cellular Therapy (FACT) guidelines. Under the direction of operational and clinical leadership, the Supervisor leads the compliance audits, corrective action process, and other quality and compliance activities designated in the Quality Management Plan and Audit Calendar. Ensures compliance with FACT, CIBMTR, and other applicable agencies by continually engaging agencies around updates, identifying and updating internal SOPs to reflect changes, and coordinating and documenting education to necessary parties. Regularly reviews status of annual competency requirements, identifies avenues to assist in meeting requirements, and notifies participants of any deficiencies throughout the year. Partners with IS, Best Practice, Clinical Transformation, analytics, patient engagement, patient safety, risk management and other teams to coordinate improvements in education, workflow, Epic, and other areas identified by project teams. Will participate in Quality Management Committee meetings/Transplant CPC meetings and collaborate with various clinical departments for planning, coordination, implementation, and monitoring of all quality management activities throughout the service line. Manages the Quality Calendar and performs associated audits. Shares audit results with leadership, proposes and implements corrective action plans. Participates in the design, creation, validation, analysis, and communication of clinical quality data as it related to organizational priorities in partnership with analytics and other relevant teams. Works closely with Data Managers to ensure data integrity and quarterly CPI requirements are met. Supports the evaluation and continual improvement of quality and safety at Swedish, as represented by the quality management system and/or other standardized practices across the enterprise. Uses standardized principles (i.e., document vetting and control) and processes (i.e., internal audits, preventative/corrective action, risk reduction, action planning) as appropriate. Remains current and knowledgeable about regulatory requirements and payor/government programs such as FACT and CIBMTR. References that information to design effective systems and processes and meets or exceeds those standards. Creates project summaries and reports, leads project committees/workgroups, and provides presentations and other communications to local and system-wide groups/teams in partnership with division leadership as needed. Participates thoughtfully and constructively in team meetings. Assists with onboarding of new team members. Maintains minimum 10 hours of cellular therapy education. Providence caregivers are not simply valued - they're invaluable. Join our team at Swedish First Hill and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them. Required Qualifications: Bachelor's Degree Nursing; graduation from an accredited school. Upon hire: Washington Registered Nurse License. Upon request: Driving may be necessary as part of this role. Caregivers are required to comply with all state laws and requirements for driving. Caregivers will be expected to provide proof of driver license and auto insurance upon request. 3 years Direct patient care. Experience with EHRs. Experience developing clinical care policies, procedures and order sets. Preferred Qualifications: Master's Degree Healthcare. 1 year Experience in a supervisory role; delegating nursing responsibilities to licensed and unlicensed personnel within a medical setting (ambulatory or acute). Why Join Providence? Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally and achieving financial security. We take care of you, so you can focus on delivering our mission of improving the health and wellbeing of each patient we serve. About Providence At Providence, our strength lies in Our Promise of “Know me, care for me, ease my way.” Working at our family of organizations means that regardless of your role, we'll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable. Posted are the minimum and the maximum wage rates on the wage range for this position. The successful candidate's placement on the wage range for this position will be determined based upon relevant job experience and other applicable factors. These amounts are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits. Applicants in the Unincorporated County of Los Angeles: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Unincorporated Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Requsition ID: 405697 Company: Swedish Jobs Job Category: Clinical Quality Job Function: Quality/Process Improvements Job Schedule: Full time Job Shift: Day Career Track: Nursing Department: 3901 SFH HEM ONCOLOGY Address: WA Seattle 1221 Madison Work Location: Swedish First Hill 1221 Madison-Seattle Workplace Type: On-site Pay Range: $57.86 - $89.83 The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. PandoLogic. Category:Quality Control, Keywords:Quality Control / Quality Assurance Manager, Location:Kirkland, WA-98083

A leading biopharmaceutical company in California is looking for a seasoned Quality Lead to define and execute the quality strategy for Development Electronic Systems, focusing on the integration of emerging technologies like AI. The ideal candidate should possess over 13 years in the pharmaceutical industry, demonstrating exceptional leadership and problem-solving capabilities. This role emphasizes cross-functional collaboration, risk management, and fostering a culture of continuous improvement while ensuring compliance with regulatory standards. #J-18808-Ljbffr

Modular Services Company is a medical product design and manufacturing leader, specializing in advanced prefabricated products such as Medical Headwalls, Footwalls, Sinkwalls, Fixed/Rotating Columns, and Movable Boom Systems. Headquartered in Oklahoma City, Oklahoma, the company focuses on innovative solutions to enhance healthcare environments. Modular's products are engineered to improve medical facility efficiency and patient care. The company remains dedicated to delivering tailored solutions to meet the unique needs of healthcare providers. Role Description This is an on-site, full-time position located in Oklahoma City, OK. The Quality Assurance Manager will oversee quality control processes and ensure all products comply with company and industry standards. Responsibilities include developing and implementing quality assurance strategies, conducting audits, managing a team to monitor processes, and leading continuous improvement initiatives. The individual will collaborate across teams to enforce production quality standards and address any quality-related challenges. Qualifications Strong experience in Quality Assurance, Quality Control, and process improvement methodologies Proficiency in conducting audits, managing teams, and implementing quality assurance strategies Knowledge of medical product design or manufacturing processes is preferred Excellent problem-solving, decision-making, and leadership skills Strong verbal and written communication abilities to collaborate across teams and departments Proficient in relevant quality assurance tools, metrics, and software Ability to work on-site full-time in Oklahoma City, OK Bachelor's degree in Quality Management, Engineering, Manufacturing, or a related field, with applicable certifications being a plus

The CQM Supervisor oversees non-clinical auditors in the Clinical Quality Management (CQM) department, ensuring regulatory compliance and the quality of processes in daily Non-Clinical Utilization Management (UM) activities, under the direction of a manager. This Supervisor is responsible for conducting live audits of UM case files, assigning drivers and presenters, and ensuring their performance is appropriate. The role also involves monitoring UM system controls and processes, specifically those that do not require clinical decisions. A solid understanding of comprehensive regulations, UM policies and procedures, the UM system, UM auditing, and quality improvement is essential for this position. Essential Duties and Responsibilities: - Familiarity with Non-Clinical UM regulations, processes, and systems. - Ability to assign workloads effectively while managing staff. - Proficient in presenting case files and conducting interviews regarding non-clinical questions. - Skilled in designing audit tools to monitor Non-Clinical UM processes completed by non-clinical staff. - Strong communication skills for effective interaction with internal clients and external customers. - Capable of training employees using Policies & Procedures (P&Ps) and audit tools. - Provide constructive feedback and exhibit strong active communication skills. - Summarize quality monitoring findings, analyze root causes, and propose quality improvement plans. - Suggest and design focused audits that help improve compliance in Non-Clinical UM processes. - Request decision support for creating and enhancing Non-Clinical UM monitoring reports based on changes to UM P&Ps. - Ensure auditors complete audits and necessary remediation within specified timeframes. - Collaborate with the Non-Clinical UM team to ensure monitored focus areas are addressed and that process quality is tracked. - Work with operational teams to evaluate the effectiveness and efficiency of process changes made for quality improvement. - Ensure that new processes are accurately implemented through reports and case file reviews. - Report issues identified to the Prior Authorization Compliance Director based on findings. - Review updated policies and procedures, and be able to update the quality monitoring tool accordingly. - Maintain all evidence related to quality monitoring projects. - Track and manage daily reports received from the decision support team. - Report any issues related to internal processes (e.g., timeliness) to the CQM manager. - Attend department meetings, in-house services, and trainings, completing acknowledgments within the required timeframe. - Perform all other duties as directed by management. Education and Experience: - Three to five (3-5) years of experience in non-clinical utilization management. - Preferred: at least two (2) years of experience in non-clinical UM supervision or auditing. - Proficiency in MS Office programs (Word, Excel, Outlook, Access, PowerPoint). - Typing speed of 60 words per minute with accuracy. - Ability to handle confidential matters responsibly. - Strong analytical, creative problem-solving, and organizational skills. - Capacity to work in a multi-tasking, high-stress environment. - Effective strategy execution within timelines, delivering quality results. - Ability to adapt and thrive in a fast-paced environment, demonstrating proactivity. - Capable of managing multiple projects simultaneously, adjusting priorities daily, and knowing when to seek assistance with conflicting priorities. - Self-motivated, assertive, ambitious, and possessing high personal ethics. - Ability to collaborate with all levels of management and establish positive working relationships across various divisions in the company. Compensation: The pay range for this position at the start of employment is expected to be between $70,304 and $72,000 annually, depending on experience. However, the base pay offered may vary based on multiple individual factors, including market location, job-related knowledge, licensure, skills, and overall experience. The total compensation package for this position may also include other elements, such as a sign-on bonus and discretionary awards, along with a full range of medical, financial, and other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), depending on the position offered. Details regarding participation in these benefit plans will be provided to employees who receive an employment offer. If hired, the employee will be in an “at-will position,” and the company reserves the right to modify base salary (along with any other discretionary payments or compensation programs) at any time, including for reasons related to individual performance, overall company performance, or market factors. As one of the fastest-growing Independent Physician Associations in Southern California, Regal Medical Group, Lakeside Community Healthcare, and Affiliated Doctors of Orange County offer a dynamic and fast-paced work environment. Employer will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the LA City Fair Chance Initiative for Hiring Ordinance.

Responsible for maintaining compliance with all State, Federal regulatory guidelines and third party payers; Accreditation standards and quality activities of the organization. Provides leadership and expertise to facilitate and support staff competency through best practice teaching, consultation, collaboration and the use of current knowledge, research and technology. Essential Functions: Ensures that there are processes in place to monitor and measure all activities related to quality assessment and performance improvement (QAPI). Provides direction and coordination of quality improvement activities utilizing continuous quality improvement principles and methodologies. Provides education and training to organization personnel on the QAPI plan, and team development. Performs clinical record review activities for data collection. Compiles, analyzes, trends and reports quality data in the following areas: hospice & palliative care quality reporting, patient care, safety, risk management, infection control, outcomes and customer satisfaction. Works collaboratively with nursing supervisors/managers/directors to assure documentation is complete and consistent with care and reflects legal requirements. Promotes professional standards of care, compliance with regulatory requirements, third-party payor reimbursement models, and organization policies and procedures through use of performance improvement methodology. Ensures complete responses to Additional Development Requests (ADRs), Comprehensive Error Rate Testing (CERT), Recovery Audit Contractor (RAC) etc., requests and participates in appeal processes. Participates in the development and annual revision of Quality Assessment and Improvement Plans and Program Evaluation. Participates in analyzing, developing, coordinating and implementing plans of correction for noted deficiencies. Makes recommendations to the education committee for mandatory education related to accreditations and compliance topics. Acts as a mentor and resource for staff with regard to performance improvement methodology, regulatory, educational and patient care issues. Participates in the evaluation, development and revision of policies and procedures for hospice. Participates on various committees related to Organizational Quality and Education. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal and professional networks. Adheres to organizational Code of Conduct, policies, procedures, protocols and processes and all regulatory and legal requirements Adheres to the C.A.R.E. Model of Service: courtesy, acknowledgement, response and empathy. Qualifications: Registered Nurse with a baccalaureate degree in nursing, preferably a Master's Degree in a health-related discipline. Minimum three (3) years' direct hospice experience may be considered in lieu of BSN degree. Requires two to three years related quality and accreditation experience. Current RN licensure in State of Michigan and maintain such licensure in accordance with applicable laws and regulations and perform within the scope specified. Extensive knowledge of Hospice regulations and standards preferred. Excellent written, verbal and interpersonal skills necessary to interact with a wide variety of staff. Is self-directed and able to work with minimal supervision. Requires knowledge of quality assessment and utilization review functions, principles and practices. Theoretical and practical knowledge of principles of adult learning and ability to develop and present educational programs. Quantitative, analytical and computer skills to collect, analyze, display and present data. The physical and sensory demands of the position include: vision, effective speech and hearing for extensive telephone contact; repetitive motion; traveling; driving or riding in motor vehicle; standing, sitting, walking, bending, reaching, and stretching; lifting up to forty five (45) pounds unassisted and the ability to assist in lifting patients using appropriate lifting techniques and/or devices. Must be able to work variable hours/shifts and/or days, including weekends. Must have ability to occasionally work extended days. Must be eligible to work in the United States.

A leading biotechnology firm located in California is seeking a Director of Quality Assurance to oversee product quality and establish specifications for clinical and commercial products. The role requires extensive experience in analytical chemistry and regulatory compliance, along with strong leadership skills in a complex matrix environment. This is a full-time on-site position offering the opportunity to lead strategic quality initiatives. #J-18808-Ljbffr

The primary responsibility for this position is to establish phase appropriate product specifications for Gilead's clinical and commercial products. In addition, this position is responsible for end to end product quality strategy and serves as the QA main point of contact on the PDM Product Strategy Team(s). The position holds a scientific and technical understanding of drug development and commercialization and able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. Job Functions Expert in analytical control systems, assuring network-wide harmonization of control systems by proactive lifecycle management, technical leadership and ownership. Provide technical oversight of product specification setting and justification based on scientific approach. Deep understanding of analytical methods (development, validation, transfer, and monitoring) and product (process development, CQA analysis, stability, comparability, etc). Ability to evaluate Global product filing strategies with core PDM Team for implementation. Provide timely support for health authority interactions on the product, authorship/review (as needed) relevant health authority information requests for in-process controls, process development (comparability), method validation, specifications, reference standard, and stability sections of regulatory submissions. Build internal knowledge and capabilities on product control strategies. Proactively share expertise with other functional groups to generate alignment and improvement opportunities. Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log. Serve as the primary Quality representative in the PDM meeting. Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones. Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner. Review and approve the strategy for change control(s) impacting the product/program lifecycle. Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints. Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option). Provide oversight for changes to drug substance and drug product CMC details. Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites. Support drug substance and drug product technology transfer, and new product launches. Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products. Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams. Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes). Perform work that requires independent decision making and the exercise of independent judgment. Serve as the delegate for direct manager, as needed, for meeting and decision making. Knowledge, Experience and Skills Well verse in technical requirements for product control systems. Strong knowledge and practical experience in analytical chemistry, including separation science, wet chemistry, physicochemical characterization or related areas. Strong experience in the assessment of technical data and scientific information is required in order to provide technical reviews for documents and regulatory submissions. In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles. In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Skilled at managing multiple projects and timelines and to facilitate meetings. In-depth understanding and execution of Quality Risk Management. Ability to track and follow up on actions. Excellent in verbal, written and interpersonal communication skills. Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way. Ability to lead and influence a matrix-based cross-functional team. Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Basic Qualifications 12+ years of relevant experience and a Bachelor's degree in science or related fields. OR 10+ years of relevant experience and a science degree MS OR 8+ years PhD Preferred Qualifications Prior Quality leadership and technical management experience in development and/or commercial programs. 15+ years of relevant experience and a Bachelor's degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, PharmD, PhD or an advanced business degree such as an MBA. Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment. Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections. Broad experience across several including process validation, drug development experience, packaging/labeling and understanding of Parenteral, Oral Solid Dosage, and Biologics. Job Requisition ID R0047720 Full Time/Part Time Full-Time Job Level Director Remote Type Onsite Required #J-18808-Ljbffr

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities Engineering Experience in Medical Device Industry Problem Solving Knowledge (Yellow or Green Belt knowledge) Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Qualifications Requirements/Knowledge/Education/Skills BBA in Engineering Knowledge in CSV Problem Solving Knowledge (Yellow or Green Belt knowledge) Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. #J-18808-Ljbffr

A leading technical solutions provider is seeking an engineer specialized in the medical device industry. The role involves designing manufacturing processes and ensuring compliance with safety regulations. Candidates should have a BBA in Engineering, knowledge in CSV, and problem-solving skills (Yellow or Green Belt). The position offers an opportunity to work with innovative technologies in a dynamic environment located in Caguas, Puerto Rico. #J-18808-Ljbffr

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities Engineering Experience in Medical Device Industry Problem Solving Knowledge (Yellow or Green Belt knowledge) Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Qualifications Requirements/Knowledge/Education/Skills BBA in Engineering Knowledge in CSV Problem Solving Knowledge (Yellow or Green Belt knowledge) Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. #J-18808-Ljbffr

A leading technical solutions provider is seeking an engineer specialized in the medical device industry. The role involves designing manufacturing processes and ensuring compliance with safety regulations. Candidates should have a BBA in Engineering, knowledge in CSV, and problem-solving skills (Yellow or Green Belt). The position offers an opportunity to work with innovative technologies in a dynamic environment located in Caguas, Puerto Rico. #J-18808-Ljbffr

Veridiam is a strategic manufacturing partner specializing in precision fabrication of components and assemblies made from exotic metals for critical applications in aerospace, defense, medical, nuclear, and space. Our roots were formed in the exacting nuclear and aerospace industries, expanded into medical where we have supplied critical components to a global customer base. Veridiam's ability to work with challenging materials such as titanium alloys, nickel-based superalloys, refractory metals, and specialty stainless steels ensures reliable, mission-ready products for our customers' most vital programs. As a trusted partner, Veridiam provides technical collaboration, quality assurance, and supply chain reliability essential to advancing innovation and operational success across these highly regulated industries and results for mission-critical parts made from titanium alloys, nickel-based superalloys, refractory metals and more. At Veridiam we recognize that talent is at the forefront of our organization and define who we are in today's industry. You will work in a highly regulated, precision manufacturing environment where safety, documentation integrity, dimensional control (“True Diameter”) and traceability are paramount. Veridiam is looking for a Materials Engineer for our El Cajon facility. Interested candidates should apply directly to our website at: Careers - Strategic Manufacturing Partner > Veridiam Position Summary Extract, research, develop, test, and improve materials used in our products and processes. Perform tests and conduct research on properties, performance and applications of metals including high-performance alloys. Analyze material behavior under various conditions and prepare technical reports. Essential Duties and Responsibilities Perform assigned routine and advanced or complex tests on raw material, product in process, re-worked material, finished goods and/or developmental samples in accordance with customer and/or quality standards/specifications. Conduct research on the properties, performance, and applications of metals including high-performance alloys such as stainless steel, titanium, and nickel alloys. Develop and test new materials to improve product durability, performance, and efficiency. Perform failure analysis and recommend design/material improvements. Analyze material behavior under various conditions (stress, temperature, corrosion, wear, etc.). Review and manage internal and external material lab test results. Develop and maintain processes for new product introduction. Prepare technical reports, specifications, and documentation for internal and customer use. Prepare, organize, and maintain necessary samples, forms, documentation and trend charts. May provide data and analysis to material review board to support resolution of issues, initial data support to supplier and/or customer notification. Ensure compliance with industry standards, safety regulations, and environmental requirements. Support process optimization and cost-reduction initiatives without compromising quality. Work collaboratively with cross-functional teams to ensure materials meet customer requirements and performance, quality and cost objectives. Provide and supply training for others in the area. Maintain clean and orderly work environment. Demonstrates ability to appear for work on time, follow directions from a supervisor, interact well with co-workers, understand and follow work rules and procedures, comply with company policies and procedures, goals and objectives, and accepts constructive feedback. Other duties as assigned, requested or needed. Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Education and Experience: Bachelor's degree in Materials Science, Materials Engineering, Metallurgy, Chemical Engineering or related field. Five (5) or more years' experience in manufacturing and/or familiarity of the international standards for testing metallic materials (ASTM E8) including steel products (ASTM A370) preferred or equivalent education and experience. Knowledge, Skills, and Abilities: Knowledge of metal forming, and/or machining methods preferred. Excellent written and verbal communication skills. Ability to read and interpret documents such as work orders, operating and maintenance instructions and procedure manuals and blueprints. Ability understand and follow standard operating and safety procedures. High-level attention to detail and commitment to quality standards. Strong problem-solving skills and technical expertise in materials science. The above statements are intended to describe, in broad terms, the general functions and responsibility levels assigned to this classification. Management has the right to change duties at any time to meet business needs. Pay Rate: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc. Veridiam is an Equal Employment Opportunity/Affirmative Action Employer. Veridiam will recruit, hire, train and promote persons into all jobs without regard to age, race, color, religion, ancestry, medical condition, sex, sexual orientation, gender identity, national origin, status as a veteran or status as an individual with a disability or any other characteristic or classification protected by law. Access to our facility (and, therefore, employment) is restricted under the International Traffic in Arms Regulations (ITAR) and/or Export Administration Regulations (EAR) to U.S. Citizens, lawful permanent residents of the United States and properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes.

A leading technical solutions provider is seeking an engineer specialized in the medical device industry. The role involves designing manufacturing processes and ensuring compliance with safety regulations. Candidates should have a BBA in Engineering, knowledge in CSV, and problem-solving skills (Yellow or Green Belt). The position offers an opportunity to work with innovative technologies in a dynamic environment located in Caguas, Puerto Rico. #J-18808-Ljbffr

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities Engineering Experience in Medical Device Industry Problem Solving Knowledge (Yellow or Green Belt knowledge) Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Qualifications Requirements/Knowledge/Education/Skills BBA in Engineering Knowledge in CSV Problem Solving Knowledge (Yellow or Green Belt knowledge) Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. #J-18808-Ljbffr

JOB SUMMARY Manage the vender set-up process, including initial vendor approval and routine re-evaluation. Serve as a subject matter expert in Medline's vendor evaluation process. Will also be responsible for coordination of third party laboratory testing. MAJOR RESPONSIBILITIES Review, approve, and upload documentation for initial approval of new Medline vendors. Review, approve, and upload documentation for re-evaluation of Medline vendors. Act as a Subject Matter Expert (SME) on Medline's vendor evaluation program. Maintain Medline's supplier audit schedule, by adding audit requests to the audit schedule and working with the audit team to ensure audits are being completed according to schedule. Analyze and compile reports on a routine basis related to Supplier Quality. Prepare reports on assessment activities, findings, and outcomes. Coordinate third party testing between product divisions and third-party testing laboratories, including negotiating pricing, service level agreements and determining the appropriate product testing to be performed. Monitors supplier performance and supports efforts to develop and implement changes for process improvement. MINIMUM JOB REQUIREMENTS Education Typically requires a Bachelor's degree in Chemistry, Biology, or related science field. Work Experience At least 2 years of experience in a medical device or pharmaceutical related field. Knowledge/Skills/Abilities Time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects. Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook). Position requires up to 25% travel PREFERRED JOB REQUIREMENTS Work Experience Knowledge of FDA requirements and experience with FDA. Knowledge of ISO 13485 requirements. Experience with supplier approvals, evaluations, re-evaluations, and monitoring Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.