Quality Technician jobs at Boston Scientific - 1524 jobs
Quality Inspector, Medical Devices - Impact Patient Care
Edwards Lifesciences Belgium 4.6
Salt Lake City, UT jobs
A leading medical technology company in Salt Lake City is seeking a qualified candidate for quality inspection roles in medical device manufacturing. The job includes performing inspections, conducting functional tests of medical products, and ensuring compliance with safety and quality standards. An H.S. Diploma is required, along with English proficiency. Ideal candidates will demonstrate strong communication abilities and attention to detail, working within a team to support patient care and environmental safety protocols.
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$39k-46k yearly est. 5d ago
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Quality Systems Lead
Alkermes 4.9
Waltham, MA jobs
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:************************************* .
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$141k-146k yearly 5d ago
Mammograph Technologist Lead/Quality Control
Kaiser Permanente 4.7
Wailuku, HI jobs
Under direct and indirect supervision, performs mammography and DEXA examinations with physician supervision; maintains responsibility for monitoring and quality control of all mammographic and DEXA studies. Monitors and assists with direction and technical operation of
mammography and DEXA examinations subsection; assists with workflow coordination. Assumes direct control of specific areas within Mammography and DEXA as assigned. Manages the Quality Control (QC) initiatives at assigned facility.
Essential Responsibilities:
+ Monitors technical and clinical performance of mammographers assigned to Mammography and DEXA section, and provides assistance to staff as needed. Remains responsible for quality control procedures for assigned Mammography and DEXA section.
+ Completes patient history/breast assessment and/or DEXA patient fracture assessment form and transmits form into the Radiology PACS system.
+ Performs mammography and DEXA studies and procedures. Positions patients, applies compression, provides immobilization means and patient counseling as required. Selects technical factors and protocols that result in optimum imaging for each individual patient. Reviews orders with peers and consults with attending Radiologists as needed. Maintains daily records of exams performed. May perform stereotactic biopsy procedures.
+ Follows all National Patient Safety Goals. Receives and double identifies patients using appropriate criteria prior to performing the study ordered. Ensures accruacy of information and data entry, while maintaining patient privacy and confidentiality. Captures required documentation in Radiology Information System (RIS.)
+ Prepares sterile fields as required and directed; prepares floor stock medications; ensures sterility of surgical packs, trays and disposables to be used in assigned area. Maintains appropriate and adequate supplies during the procedures. Remains proficient in performing breast localizations as pre-biopsy procedure; remains proficient in performing stereotactic breast biopsy if applicable.
+ Assists radiologist during exams and procedures as needed; capturing specific mammography images and assisting with biopsy specimen collection. Operates and understands all features and performance capabilities of the mammography and DEXA systems: performs system quality control (QC) as required. Demonstrates sufficient knowledge for all quality control tests to include daily, weekly, monthly, quarterly, and semi-annual testing; performs quality control tests when assigned. Maintains FDA and MQSA records, guidelines to meet accreditation standards.
+ Post processes and performs quality control (QC) of mammography images and DEXA images as required; prepares images for Radiologist interpretation, and transmits images to the Diagnostic Imaging PACS system.
+ Maintains working knowledge of all department equipment and devices. Recognizes, corrects, or reports radiographic equipment malfunctions to Service Engineer and/or Physicist.
+ Monitors and assures prompt, efficient patient flow with minimal waiting time; provides assistance during patient schedule conflicts; advises receptionists as to appropriate schedule revisions and assures efficient patient flow.
+ Assumes responsibilities for the needs of patient during procedure. Provides fear/stress reducing service-oriented communication with patient; explaining procedure; answering questions; providing encouragement. Emphasizes a personalized, individualized, compassionate patient care atmosphere at all times. Dismisses patients for transport and/or assists with patient transport at end of procedure.
+ Provides instructions on appropriate safety measures to patients, family members, and hospital staff as required; ensures appropriate safety precautions are followed. Applies appropriate measures (ALARA Principles) for minimizing radiation exposure. Captures and records radiation dose delivered during the procedure.
+ Functions as part of resuscitation team during Code Blue and/or Rapid Response Team situations.
+ Orients and trains (mentors) new personnel regarding subsection operations as needed. Trains mammographers to maintain high level of image quality as well as adherence to departmental rules, standards and protocols. Maintains high personal level of competency in this area to provide constant resource for teaching and training.
+ Maintains all materials needed and linen supply on daily basis; maintains general order and cleanliness of room assigned.
+ Pursues ongoing continuing education.
+ Attends departmental meetings and/or inservice presentations as needed or required. Reads and initials minutes of such meetings when excused absence precludes attendance.
+ Evaluates productivity and patient care performances. Reports substandard levels appropriately. Advises manager of real or potential problems concerning discipline, morale, technical competency, interpersonal relations, etc.
Basic Qualifications:
Experience
+ Minimum three (3) years mammography experience.
Education
+ Associates degree in radiologic technology; or two (2) years of experience in a directly related field.
+ Specialty training in technical and interpretive aspects of mammography.
License, Certification, Registration
+ Radiographer License (Hawaii)
+ American Registry of Radiologic Technologists Certificate - Mammography Technologist
+ Basic Life Support
Additional Requirements:
+ Ability to coordinate work of others.
Preferred Qualifications:
+ Team Leader experience.
+ MQSA and/or ACR Quality Control experience in high volume setting.
+ Teaching or training experience.
+ Training in MQSA and ACR Quality Control initiatives.
COMPANY: KAISER
TITLE: Mammograph Technologist Lead/Quality Control
LOCATION: Wailuku, Hawaii
REQNUMBER: 1378210
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.
$91k-106k yearly est. 6d ago
First Shift Medical Device Quality Inspector
Edwards Lifesciences Belgium 4.6
Salt Lake City, UT jobs
A leading medical technology company is seeking a Quality Inspector in Salt Lake City. This position involves performing inspections and functional testing of medical device products, ensuring compliance with specifications. Candidates must have a high school diploma and proficient English skills. Attention to detail and ability to work independently are essential. The job includes a shift from Monday to Thursday, with a pay rate of $19.44/hr and requires COVID-19 vaccination as a condition of employment.
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$19.4 hourly 5d ago
Night Shift Medical Device Quality Inspector
Edwards Lifesciences 4.6
Salt Lake City, UT jobs
A leading medical technology company is looking for a Quality Inspector in Salt Lake City. The role involves visual, dimensional, and functional inspections of medical devices, ensuring they meet design specifications. Candidates must have a high school diploma and strong attention to detail. Preferred skills include manual dexterity and basic computer skills. The position offers a pay rate of $19.44/hr and is scheduled Monday to Thursday from 3:45pm to 2:15am.
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$19.4 hourly 3d ago
Senior Quality Systems Engineer (Remote, US)
Getinge 4.5
New York, NY 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.
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$112k-120k yearly 5d ago
QA Radiology Technician
NYC Health + Hospitals/Correctional Health Services 4.7
New York, NY jobs
NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers.
NYC Health + Hospitals/Correctional Health Services is one of the nation's leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation's largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City's criminal justice reform efforts.
The Quality Assurance (QA) Radiological Technologist position encompasses responsible, administrative and clinical activity of varying degrees of latitude. Clinical level judgement is needed in the daily supervision of radiological functions and patient care, and departmental projects.
Responsibilities include:
Review exam orders, consult with radiologist, schedule patients and arrange for transportation as indicated.
Identify patient and document all information pertinent to final report in the RIS and on images (PACS).
Prepare all patients (infants, children, adolescents, adults and geriatric) for radiological procedures requested by the clinician. Arrange for proper protection of patients, public and staff from infectious diseases/materials.
Perform all general diagnostic imaging and routine examination in CT and Angiography.
Assists in performing daily checks of radiographic imaging equipment, immobilization devices and other necessary accessories.
Enters data and maintains documents and logs as required and mandated by the department QA guidelines and various regulatory agencies.
Maintains adequate stocks of supplies and materials needed for use in the department.
Checks equipment for defects prior for use and assures proper use of such equipment through instruction and review.
Report any unexpected patient incidents in accordance with the occurrence report protocol.
Maintain and exercise all mandated radiation safety regulations. Maintain basic care of all the imaging equipment. All malfunctions are to be reported to management staff whether mechanical, electrical or suspect and service request documentation completed. Maintain a clean and safe work environment for both patients and staff.
Perform other duties as deemed necessary (by supervisory or administrative staff) in the event of emergencies or disasters.
Continue professional growth and development of job-related skills on an ongoing basis. Participate in continuing education activities.
Ensure all examinations are accessioned, documented and sent to PACS for reading. Monitor PACS and RIS incomplete worklists to ensure all exams are completed.
In accordance with HIPAA (the Health Insurance Portability and Accountability Act), staff members will exercise due diligence in ensuring patient privacy and confidentiality.
Identifies activities that the network has implemented to promote patient safety and takes all necessary precautions to ensure a safe environment for patients, visitors and staff.
In addition to the Radiology Technologist job functions, the QA Technologists is responsible for the following:
Organize and file maintenance reports for each building in regards to dentistry and radiology x-ray equipment and ensure dentistry and x-ray equipment follow the Department of Health codes, policies and procedures.
Participates in quality assurance activities, including coordination, control and maintenance of technical equipment.
Establish a daily/weekly/monthly quality control routine for monitoring, evaluating, and maintenance of X-ray equipment to ensure optimal performance and stability.
Documenting and maintaining records for the quality control program in accordance with applicable regulations, legal requirements, accrediting agencies and recommendations from equipment manufacturers.
Performs research and participates in special projects involving evaluation of equipment and delivery of service.
Work with our radiologists to obtain updated documentation of primary diagnostic monitors.
Distribute/collect dosimeter badges from each employee/facility that works with x-ray equipment.
Recommends area assignment of personnel to coordinate activities within the department with other activities and services and represents the department in interdepartmental operations and meetings.
May be assigned duties and responsibilities of X-ray Director in regards to radiology department workflow.
Minimum Qualifications:
Assignment Level III
1. For Supervisory Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and two (2) years of Radiologic Technologist experience performing duties consistent with Assignment Levels I and II, one (1) year of which must have been in a supervisory capacity.
2. For Specialized Imaging Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and possession of a current advanced- level certification for the performance of these procedures.
NYC Health and Hospitals offers a competitive benefits package that includes:
Comprehensive Health Benefits for employees hired to work 20+ hrs. per week
Retirement Savings and Pension Plans
Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts
Loan Forgiveness Programs for eligible employees
College tuition discounts and professional development opportunities
College Savings Program
Union Benefits for eligible titles
Multiple employee discounts programs
Commuter Benefits Programs
$36k-57k yearly est. 18h ago
Senior Quality Systems Engineer (Remote) - Drive QMS Excellence
Getinge 4.5
New York, NY jobs
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.
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$78k-103k yearly est. 5d ago
Senior Product Quality Lead - CMC & Regulatory Strategy
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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.
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$114k-146k yearly est. 4d ago
Product Quality Lead
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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
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$114k-146k yearly est. 4d ago
Global Supplier Quality Leader
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
A leading biopharmaceutical company in California is seeking a Senior Director for Global Supplier Quality. The successful candidate will lead a team of Quality Professionals, ensuring compliance with GMP standards while managing supplier quality initiatives. This role requires extensive experience in biopharmaceutical management, exceptional leadership skills, and a strong understanding of regulatory requirements. Candidates should have a solid educational background in science and proven leadership experience in complex organizations. Competitive salary & benefits are offered.
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A global healthcare company is seeking a Senior Quality Engineer specializing in Quality Operations in Wayne, NJ. The successful candidate will oversee and improve the quality of manufacturing processes while ensuring compliance with regulatory standards. With a focus on continuous improvement, candidates should have at least six years of experience in Quality or Engineering, specifically in the medical device industry. A Bachelor's degree in Engineering or Science is required, alongside strong analytical and problem-solving abilities.
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$81k-105k yearly est. 3d ago
Supervisor , Continuous Quality Monitoring
Regal Medical Group 3.8
Los Angeles, CA jobs
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.
$70.3k-72k yearly 4d ago
Clinical Quality Coordinator
St. John's Riverside Hospital 4.7
Yonkers, NY jobs
The Quality Registered Nurse plays a vital role in advancing the hospital ' s journey toward the ANCC Pathway to Excellence designation. This position supports the development of a positive practice environment by leading quality improvement initiatives, promoting nursing excellence, and ensuring alignment with the six Pathway Standards: Shared Decision-Making, Leadership, Safety, Quality, Well-Being, and Professional Development.
Lead and coordinate quality improvement projects that align with Pathway standards, focusing on patient safety, clinical outcomes, and nursing practice.
Support shared governance structures by facilitating nurse-led councils and promoting frontline nurse involvement in decision-making.
Monitor and report on nursing-sensitive indicators, including infection rates, falls, medication errors, and readmissions.
Conduct audits and root cause analyses to identify opportunities for improvement and ensure compliance with evidence-based practices.
Collaborate with nursing leadership to develop and implement strategies that foster a respectful, safe, and empowering work environment.
Educate staff on Pathway standards, quality initiatives, and professional development opportunities.
Assist in preparing documentation for the Pathway application, including narratives, outcome data, and survey coordination.
Promote nurse well-being by supporting initiatives that address physical and mental health, recognition, and work-life balance.
How This Role Supports Pathway to Excellence:
The Pathway to Excellence designation requires hospitals to demonstrate excellence across six standards: [*********************
Shared Decision-Making - Quality Nurses help facilitate nurse-led councils and shared governance.
Leadership - They collaborate with nurse leaders to promote transparency, accountability, and mentorship.
Safety - They lead initiatives to reduce harm and foster a respectful workplace.
Quality - They monitor outcomes and drive continuous improvement.
Well-Being - They support programs that promote nurse wellness and recognition.
Professional Development - They help create learning opportunities and career advancement pathways.
Requirements
Bachelor's degree in Nursing (BSN) required, Master's preferred
Minimum of 3-5 years of clinical experience in a hospital setting.
Experience in quality improvement, patient safety, or nursing excellence programs preferred.
Familiarity with ANCC Pathway to Excellence standards and survey process.
Strong analytical, communication, and project management skills.
Proficiency in data analysis tools and electronic health records.
Registered Nurse (RN) with active New York State licensure.
$47k-74k yearly est. 1d ago
Engineer, Network - IT Infrastructure - Full Time (On-site, Cortland)
Guthrie 3.3
Cortland, NY jobs
located in Cortland, NY. The Engineer, Network is responsible for the implementation and support of network infrastructure, including LAN, WAN, WLAN and SDWAN to support critical healthcare operations across The Guthrie Clinic (TGC). This role ensures high availability and performance for clinical systems, patient care services, and administrative functions across the hospital network. The Engineer collaborates with IT teams, vendors, and hospital stakeholders to align network solutions with organizational goals and regulatory requirements. This position will be a technology advocate throughout the organization for the effective application of technology to meet business needs and to support business changes and growth. Technology functions include network infrastructure, architecture and protocols (routers, switches, wireless controllers, access points, firewalls, network appliances), network automation and operations, patch management, application delivery, monitoring and cloud computing.
Experience:
1. Preferred three to five (3 to 5) years of experience in implementing and managing complex network infrastructure in an enterprise environment; healthcare experience preferred.
2. Highly experienced information systems professional with a strong technical background and proven track record of accomplishments in a large, complex multi-level organization.
3. Experience in network protocols (e.g., TCP/IP, BGP, OSPF, MPLS) and technologies (e.g., Cisco, Extreme, Palo Alto).
4. Proficiency in network security tools (e.g., firewalls, IDS/IPS, NAC).
5. Knowledge of software-defined networking (SDN) and cloud-based network solutions (e.g., AWS, Azure).
6. Knowledge of Azure networking services (e.g., MS Azure VNET, ExpressRoute, vWAN, etc.)
7. Proficient with monitoring and logging tools for access management and troubleshooting using such tools as Syslog, ACS, Netflow, Solarwinds and protocol analyzers.
8. Knowledge of network security and encryption standards.
9. Intermediate troubleshooting skills.
10. Ability to work with network security devices such as Palo Alto, Cisco ASA.
11. Experience with ITSM functionalities such as change control, CMDB and ticketing systems.
12. Strong knowledge of healthcare information systems (e.g., Epic, Cerner), cybersecurity and clinical operations.
13. Prior experience delivering high availability systems in a 24/7 environment across geographically dispersed business units.
14. Demonstrated ability to facilitate evaluation of technologies and achieve consensus on technical standards and solutions among a diverse group of information technology professionals.
15. Demonstrated commitment to customer service who has provided responsive and effective support, developed solid working relationships with customers, and delivered high quality, value-added services that met/exceeded customer expectations.
- Equally adept at developing technology strategies and the operation of existing technical infrastructures. Significant experience and knowledge of computing architecture and implementation of networked computing structures.
1. Polished professional with demonstrated information technology experience and strong communication skills that can rapidly gain and maintain credibility with customers and IT colleagues.
Education:
1. Bachelor's degree in Information Technology, Computer Science, Healthcare Administration or related field strongly desired or an equivalent combination of education and experience.
Licenses/Certifications:
1. Preferred certifications include CCNA
Essential Functions:
- Responsible for installation and maintenance of network devices.
- Monitors functions of network devices to ensure acceptable performance.
- Creates and maintains documentation related to network configuration and network topologies.
- Serves as subject matter expert across network technologies and solutions supporting LAN, WAN, WLAN and SDWAN.
- Troubleshoots and resolves LAN, WAN, WLAN and SDWAN incidents.
- Provide level 2 escalation support and troubleshooting to resolve complex network incidents and tasks.
- Anticipates and provides solutions for complex problems and issues, recommends upgrades and enhancements. Rapidly absorbs complex technical and conceptual information to identify issues and implications. Able to present understandable alternatives to both technical and non-technical individuals at all levels of the organization.
- Monitors industry trends, maintains knowledge of developments in network infrastructure, architecture and protocols, network automation and operations, patch management, application delivery, monitoring and cloud computing.
- Maintain current working knowledge of IT best practices and innovative solutions within both healthcare and industry. Identifies leading edge technologies for potential early adoption that will result in service differentiation and create competitive advantage. Collaborates with other TGC IT departments, TGC management and business leaders assisting in the evaluation and validation of emerging technologies. Identifies strategies to mitigate risk associated with leading edge technologies.
- Promotes the use of TGC's PMO methodology and standards to manage IT initiatives.
- Demonstrates commitment to customer service by providing responsive and effective support, developing solid working relationships with customers and IT colleagues, and delivering high quality, value-added services that exceed customer expectations.
- Demonstrates a commitment to excellence in Customer Service with all internal and external customers of TGC.
- Willingness to travel between sites in the TGC Pennsylvania/New York regional footprint (Sayre, Towanda, Troy, Corning, Cortland, Binghamton, etc.)
- Performs related duties as assigned and unrelated duties as requested.
Other Duties: Other duties as assigned
Pay Range: Minimum $41.40/hr, Maximum $64.61/hr
Company: Datascope Corp.
Remote Work: 1-2 days at home (site based)
Salary Range: $112k-$125k plus 10% bonus (depending on overall c)
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
As a Sr. Quality Engineer specializing in Quality Operations, you will be responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.
Job Responsibilities and Essential Duties
Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Provide mentorship and guidance to new Engineers/Interns within the organization.
Required Knowledge, Skills and Abilities
Bachelor's Degree in Engineering, Science, or other related field is required. ASQ, CQE, Six Sigma Green Belt or other applicable certifications are a plus.
Minimum 6 years' experience in Quality or Engineering.
Experience in a medical device or pharmaceutical industry.
Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
Project management and leadership experience is desirable.
Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
Ability to work effectively in a cross-functional team environment.
Ability to review and understand technical standards and their requirements for products.
Office and manufacturing/ warehouse floor settings with occasional exposure to test laboratory environments.
May work extended hours during peak business cycles.
The Base Salary for this position is a minimum of $ 112,000 and a maximum of $125,000 and an annual bonus of 10%
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
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Parental and Caregiver Leave
Tuition Reimbursement
Getinge 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, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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$112k-125k yearly 3d ago
Field Product Engineer: Bridge Tech & Customer Impact (Travel)
Persona 4.3
San Francisco, CA jobs
A leading identity verification platform in San Francisco is seeking a Field Product Engineer to build lasting relationships with customers and support their technical needs. This role requires 1-3 years of experience in a technical position and offers exposure to business growth, dynamic challenges, and mentorship opportunities. The position combines hands-on support and collaboration with product teams, allowing you to impact the company while honing your own skills in a supportive environment. Enjoy a comprehensive benefits package and a dynamic workplace culture.
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A leading technology company in Boston seeks a Senior DocuSign Engineer to lead the design and implementation of DocuSign solutions. The role requires over 5 years of experience in DocuSign, strong technical expertise, and collaboration with cross-functional teams. Ideal candidates will have a Bachelor's degree in Computer Science and a proven track record in optimizing contract management workflows. The position offers competitive compensation and extensive benefits.
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$91k-132k yearly est. 5d ago
Engineer, Network - IT Infrastructure - Full Time (On-site, Binghamton)
Guthrie 3.3
Binghamton, NY jobs
located in Binghamton, NY. The Engineer, Network is responsible for the implementation and support of network infrastructure, including LAN, WAN, WLAN and SDWAN to support critical healthcare operations across The Guthrie Clinic (TGC). This role ensures high availability and performance for clinical systems, patient care services, and administrative functions across the hospital network. The Engineer collaborates with IT teams, vendors, and hospital stakeholders to align network solutions with organizational goals and regulatory requirements. This position will be a technology advocate throughout the organization for the effective application of technology to meet business needs and to support business changes and growth. Technology functions include network infrastructure, architecture and protocols (routers, switches, wireless controllers, access points, firewalls, network appliances), network automation and operations, patch management, application delivery, monitoring and cloud computing.
Experience:
1. Preferred three to five (3 to 5) years of experience in implementing and managing complex network infrastructure in an enterprise environment; healthcare experience preferred.
2. Highly experienced information systems professional with a strong technical background and proven track record of accomplishments in a large, complex multi-level organization.
3. Experience in network protocols (e.g., TCP/IP, BGP, OSPF, MPLS) and technologies (e.g., Cisco, Extreme, Palo Alto).
4. Proficiency in network security tools (e.g., firewalls, IDS/IPS, NAC).
5. Knowledge of software-defined networking (SDN) and cloud-based network solutions (e.g., AWS, Azure).
6. Knowledge of Azure networking services (e.g., MS Azure VNET, ExpressRoute, vWAN, etc.)
7. Proficient with monitoring and logging tools for access management and troubleshooting using such tools as Syslog, ACS, Netflow, Solarwinds and protocol analyzers.
8. Knowledge of network security and encryption standards.
9. Intermediate troubleshooting skills.
10. Ability to work with network security devices such as Palo Alto, Cisco ASA.
11. Experience with ITSM functionalities such as change control, CMDB and ticketing systems.
12. Strong knowledge of healthcare information systems (e.g., Epic, Cerner), cybersecurity and clinical operations.
13. Prior experience delivering high availability systems in a 24/7 environment across geographically dispersed business units.
14. Demonstrated ability to facilitate evaluation of technologies and achieve consensus on technical standards and solutions among a diverse group of information technology professionals.
15. Demonstrated commitment to customer service who has provided responsive and effective support, developed solid working relationships with customers, and delivered high quality, value-added services that met/exceeded customer expectations.
- Equally adept at developing technology strategies and the operation of existing technical infrastructures. Significant experience and knowledge of computing architecture and implementation of networked computing structures.
1. Polished professional with demonstrated information technology experience and strong communication skills that can rapidly gain and maintain credibility with customers and IT colleagues.
Education:
1. Bachelor's degree in Information Technology, Computer Science, Healthcare Administration or related field strongly desired or an equivalent combination of education and experience.
Licenses/Certifications:
1. Preferred certifications include CCNA
Essential Functions:
- Responsible for installation and maintenance of network devices.
- Monitors functions of network devices to ensure acceptable performance.
- Creates and maintains documentation related to network configuration and network topologies.
- Serves as subject matter expert across network technologies and solutions supporting LAN, WAN, WLAN and SDWAN.
- Troubleshoots and resolves LAN, WAN, WLAN and SDWAN incidents.
- Provide level 2 escalation support and troubleshooting to resolve complex network incidents and tasks.
- Anticipates and provides solutions for complex problems and issues, recommends upgrades and enhancements. Rapidly absorbs complex technical and conceptual information to identify issues and implications. Able to present understandable alternatives to both technical and non-technical individuals at all levels of the organization.
- Monitors industry trends, maintains knowledge of developments in network infrastructure, architecture and protocols, network automation and operations, patch management, application delivery, monitoring and cloud computing.
- Maintain current working knowledge of IT best practices and innovative solutions within both healthcare and industry. Identifies leading edge technologies for potential early adoption that will result in service differentiation and create competitive advantage. Collaborates with other TGC IT departments, TGC management and business leaders assisting in the evaluation and validation of emerging technologies. Identifies strategies to mitigate risk associated with leading edge technologies.
- Promotes the use of TGC's PMO methodology and standards to manage IT initiatives.
- Demonstrates commitment to customer service by providing responsive and effective support, developing solid working relationships with customers and IT colleagues, and delivering high quality, value-added services that exceed customer expectations.
- Demonstrates a commitment to excellence in Customer Service with all internal and external customers of TGC.
- Willingness to travel between sites in the TGC Pennsylvania/New York regional footprint (Sayre, Towanda, Troy, Corning, Cortland, Binghamton, etc.)
- Performs related duties as assigned and unrelated duties as requested.
Other Duties: Other duties as assigned
Pay Range: Minimum $41.40/hr, Maximum $64.61/hr
$41.4-64.6 hourly 4d ago
Senior Business Intelligence Engineer, IT Business Intelligence, Full Time, Days
Jackson Health System 3.6
Miami, FL jobs
Jackson Health System
Department: IT-Business Intelligence
Shift details: Full-Time, Days, Monday-Friday
Hybrid and Onsite twice a week
Why Jackson:
Jackson Health System is a nationally and internationally recognized academic medical system offering world-class care to any person who walks through our doors. For more than 100 years, Jackson has evolved into one of the world's top medical providers for all levels of care, no matter if it's for a routine patient visit or for a lifesaving procedure. With more than 2,000 licensed beds, we are also proud of our role as the primary teaching hospital for the University of Miami Miller School of Medicine.
Here, the best people come together to deliver Jackson's mission for our diverse communities. Our employees are committed to providing the best CARE by demonstrating compassion, accountability, respect, and expertise in everything we do.
Position Summary:
The Senior Business Intelligence Engineering serves as a technical lead and ensures the delivery of high-quality data solutions to support data-driven decision-making across the organization. Collaborates closely with both the IT Data Engineering team and various business departments to ensure data is delivered efficiently and effectively for reporting and analysis.
Duties & Responsibilities:
Serves as a technical lead and mentor a team of BI Engineers in the development and maintenance of BI solutions.
Provides technical guidance and expertise on data warehousing, ETL processes, and BI tools.
Designs and implements complex data pipelines and data models in cloud based data platforms like Snowflake and on-premises environments like MSSQL.
Collaborates with Data Engineering to define and enforce data quality standards.
Works closely with business stakeholders to gather requirements and translate them into technical solutions.
Leads the development and implementation of BI best practices and standards. Contribute to data governance initiatives and ensure compliance with data security policies.
Responsive to emails and calls/texts within a reasonable amount of time.
Is attentive to ongoing issues or questions and replies back consistently.
Ensures team members are replying and following up on correspondence.
Takes initiative to intervene in issues that may arise.
Works proactively to ensure department best practices are followed.
Intervenes when observing improper procedure or practices. Performs other related duties as assigned.
Required Qualifications:
Experience:
Generally requires 3 to 5 years of related experience.
Cloud-based data warehousing experience such as Snowflake, Azure, AWS, or similar highly preferred.
Data Visualization experience such as Tableau or similar highly preferred.
Education:
Bachelor's degree in Computer Sciences or related field is required.
Credentials:
Valid license or certification is required as needed, based on the job or specialty.
Jackson Health System is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other status protected by law.