Quality Systems Lead Jobs

Perform configuration and change management activities in support of vendor enhancements and customer requirements.

IT System Administration/Vault Owner in Veeva vault (Quality, RIM, Clinical), learning management system, validation lifecycle management system, electronic signature systems.

Validation Lifecycle Management System (ValGenesis, HP ALM, etc.), Change control, document management systems (Veeva, Documentum, etc.), DocuSign/Adobe Sign.

Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 3 to 5 years’ experience.

Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.

Ability to interpret and apply GxPs, regulatory requirements, Computer Systems Validation (CSV), SDLC, and industry best practices.

Excellent communication, collaboration, and team management skills.

Strong hands-on experience working with Defect and Test Management tools like JIRA and TestRail

Collaborate closely with cross-functional teams, including product managers, developers, and other stakeholders, to understand requirements and user stories.

Proficiency in test management tools, issue tracking systems, and relevant software development methodologies.

Strong experience working in a SaaS enabled environment with product(s) supporting multi-tenant features/capabilities.

Lead and manage a team of QA analysts / engineers, fostering a culture of quality, collaboration, and continuous improvement.

Managerial/Supervisory experience, leadership, and communication skills.

Have knowledge of measurement equipment.

Bachelor's degree or equivalent experience

Strong experience in manufacturing quality, supply quality assurance, supplier product quality development

Experience in managing Quality Engineering processes and operations, experience with problem-solving tools, and Quality Standards

Previous experience as a quality

Review and process documents to ensure adherence to document management procedural requirements (e.g. formatting, templates) and document life-cycle.

Experience working with electronic Document Management Systems such as Veeva, TrackWise, MasterControl, ComplianceWire or others similar is preferred.

Ability to work cross-functionally with colleagues of various levels of experience and management.

Provides end-user support, guidance, and training on Document/Records/Training Management processes.

Manage periodic review process to ensure controlled documents are up to date with internal and regulatory requirements.

Knowledge of GxP, ICH, EU and CFR requirements and regulations.

Compiles quality metrics for monthly quality councils and annual management reviews.

2-5 years related experience preferably in a USDA or FDA regulated industry.

Must possess strong oral and written communication skills and the ability to work independently.

Must have experience with Internal and External Audits.

Ability to effectively review in-process and product final testing to ensure compliance with requirements.

Strong computer skills including Outlook, PowerPoint, Excel, Word.

Excel in time and project management skills with the ability to manage many diverse tasks simultaneously.

Excel at written, oral and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences.

Have a broad knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.

Review of system records for assignment and closure.

Assisting Senior Quality Systems employees in support of maintaining, monitoring and improving quality system elements. This may include support in:

Assisting with the delivery of training, such as scheduling training sessions, maintaining rosters and collecting feedback.

At least 5 years of experience in Quality Management Systems (experience developing new quality systems in start ups is preferred)

Define a roadmap for ISO 9000 (and relevant standards) Quality System Certification

Create a company dashboard for quality KPI in collaboration with the other quality managers and relevant stakeholders

Strong knowledge of quality tools and methodologies (APQP, PPAP, FMEA, SPC; Six Sigma)

Support the formal definition of internal processes with a specific focus on “critical to safety” and “critical to quality” processes

Develop the Company Quality Manual and relevant procedures

Extensive experience of contemporary design control and risk management practices, ISO, FDA design control standards and requirements.

Experience developing regulated medical device systems that strictly adhere to design controls and quality management system requirements.

Proficiency withrequirements management and system modeling tools.

Excellent prioritization and project management skills.

Experience coordinating technology designs with architectural requirements and constraints.

Demonstrated experience generating technical documentation such as requirements, specifications, engineering reports, plans & procedures.

Carry out other duties as assigned by management.

Strong interpersonal skills and the ability to manage through influence.

Ensure the proper control and storage of appropriate records, and manage the filing of controlled documents.

Excellent verbal and written communication skills.

Demonstrated analytical, critical thinking, and strategic skills.

Five plus years’ relevant experience in hands on manufacturing

Support Quality Manager in Supplier quality documentation procedures

Support Quality Manager in customer RMA documentation procedures

Support Quality Manager in the documenting day to day quality activities

Working knowledge in reading and interpreting drawings, technical specification and industry standards.

Knowledge of a wide variety of product functional inspection and test equipment and methodologies

Assocaite degree or 3+ years of relevant work experience

Submit new measure templates to the client and content managers for publication.

Support the Program Manager to develop the overall timeline and roadmap.

Other duties as identified by the Program Manager, Data Governance Lead or client.

Strong verbal and written communication skills

Master’s degree in nursing or healthcare Informatics and 10 years’ experience in healthcare IT

5 years’ experience with quality measure development

Ability to have strong personable skills in communication, influence and basic email conversation

2+ years’ experience in automotive diagnosis, servicing, and repair techniques of automobiles (may be substituted for experience in production at Tesla)

Associate degree or Certificate in Automotive Technology or the equivalent in experience and evidence of exceptional ability

Ensure no cars leave respective area with open NCs

Build solid relationships in respective zone/pitches

Joint effort to inspect and repair vehicles at in-line when defects arise

Proveer retroalimentación de acuerdo con los resultados siguiendo un formato formal de reporte.

Buenas destrezas de comunicación en inglés y español.

Disponibilidad para trabajar horas extras.

Mantener y seguir prácticas de un ambiente de trabajo seguro.

Demostrar liderato e iniciativa propia. Trabajar eficientemente y poder trabajar proyectos individualmente.

Puntualidad y responsabilidad en su área de trabajo.

Develop, implement, and ensure that the Aspen Management System conforms to customer, internal, regulatory/legal, and certifying organization requirements.

Coordinates and plans, in conjunction with the site Quality Manager, Management Reviews and Internal audit schedules.

Overall implementation, sustainability of ISO9001 / IATF16949 Certification including any applicable customer specific requirements.

Manages the Aspen Management System including documentation creation, update, and control - Responsible for activities involving quality assurance.

Prepare and provide written and oral reports, communications and/or presentations to management around the development / status of Audits.

Support and lead CAR management system in CPro for all Aspen entities.

Project: run quality management review process, project manage quality improvement plan

Bachelor’s Degree plus 7+ years of experience

10+ years of relevant experience

Main Responsibilities include: Managing teams with focus on policy and strategy implementation and control rather than development.

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

Train internal/external staff on quality management system requirements.

Project and team management skills

Experience with quality management system development – required

Ensures that the quality management system demonstrates regulatory compliance per QSR, ISO, and other applicable regulations.

Prepare management representative meeting data/presentation and may be assigned management representative for assigned facility.

Trend Quality data. Monitor trends and create reports for management review.

Manage the Veeva QMS state of compliance including change management and validation.

Assist with preparation and facilitation of Management Review meetings.

Provide administrative back up for the Document Control Specialist for the electronic Quality Document Management system (Veeva Vault QualityDocs).

Auditing experience with certification preferred.

Manage Veeva account requests, creation, and modifications.

Quality trending, metrics generation, and KPI experience.

Bachelor's degree in a relevant field such as Quality Management, Life Sciences, Engineering, or equivalent experience.

Proven experience in quality systems management, audits, and regulatory compliance, preferably in the life science SaaS industry.

Certifications in quality management or regulatory affairs (e.g., ASQ, RAPS) are a plus.

Document Control and Record Management:

Implement effective record management practices to maintain accurate and readily accessible records of quality-related activities.

Provide training to employees on quality system procedures, regulations, and compliance requirements.

· In‐depth knowledge of cGMP systems and requirements

· Report progress as required by department manager

· Excellent collaboration skills and ability to work with cross functional group

· Investigation and Root Cause analysis experience in facilities, engineering, manufacturing, or QC

· Excellent communication and planning skills

· Microsoft Office and Excel experience is a must

Previous experience working with Document Control Systems and Quality Management Systems, Regulations, and Standards

Strong organizational and project management skills, with attention to detail and accuracy

Medical Benefits – We offer a range of policies through TriNet

We are looking for an experienced Quality Systems Manager to join our team.

Perform other ISO 13485 and 21 CFR 820 related activities as assigned by reporting manager.

Perform any other related activities assigned by reporting manager.