Sr Manager Quality Systems Jobs

Excellent time management, facilitation, and organizational skills.

10 years of project management experience in Medical Device, Pharmaceutical or other highly regulated industries

Knowledge and experience implementing Validated Product System (PLM, eQMS, MES, etc.)

Bachelor’s degree in Business, IT, Engineering, Project Management, or equivalent.

Strong leadership, diplomatic and motivational skills including the ability to lead up, across and down multiple business and technology organizations.

Flexible with proven ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities.

MCSE 2012/2016 or VCP 6/6.5 certification plus

7+ Years of experience in the IT field is preferred

Experience with Cisco, Meraki, Datto, VMware, Office 365, platform, and Advanced Support on Mac OS a plus

AWS or Azure experience a plus

Design, implement and support cloud infrastructure

Provide support and troubleshooting to resolve technical issues for end users

MCSE 2012/2016 or VCP 6/6.5 certification plus

7+ Years of experience in the IT field is preferred

Experience with Cisco, Meraki, Datto, VMware, Office 365, platform, and Advanced Support on Mac OS a plus

AWS or Azure experience a plus

Design, implement and support cloud infrastructure

Provide support and troubleshooting to resolve technical issues for end users

Project Management means getting things down on paper. Includes project planning, business analytics, documentation and diagraming.

• Design, implementation and support of datacenter systems such as environmental controls and power management.

Flexible health-and-wellness benefits, including medical insurance, prescription drug coverage, dental insurance, vision care, flexible spending accounts, and more.

Approachability to build successful relationships with the associations we support and other departments within the bank.

Broad Participation to engage in topics that are important to the team but not necessarily part of your day to day.

Technical Ability to solve the complex problems presented and be a true subject matter expert.

Manage all documentation and reporting requirements for the quality system

Prepares and presents technical and program information to team members and management.

Performs quality engineering reviews and/or design documentation for compliance with stated requirements, including vendor quality specifications and company quality records.

Any other requirements as needed

Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work.

Excellent communication skills (verbal and written). Bilingual English/Spanish preferred but not required.

Experience working with IATF 16949 and/or ISO9001 quality management systems

Qualifications / Education / Experience

Working knowledge of product qualification testing, inspection tools & equipment, supplier quality activities

BS degree in an engineering discipline with experience working on product/process projects preferably within a manufacturing environment

Demonstrated experience supporting root cause analysis/problem solving: 8D, 3x5Y, Shainin DOE

Demonstrated excellent written & oral communication skills

Two or four-year Degree in Electrical or Controls Engineering or equivalent degree / experience

Industrial electrical hands-on experience and troubleshooting, including 480V 3-phase, 110 VAC, and 24VDC systems

Experience with installing and maintaining many types of software and hardware

Strong organization and problem solving skills with a drive for results and the ability to handle multiple tasks and teams

Americans with Disabilities Act (ADA)

Available to work all days and shifts (24 hours a day, 7 days a week operation, including holidays)

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

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

Self-managed and ability to work in a fast-paced, remote environment. Effective time management and prioritization skills.

Implement and manage changes to ensure overall program goals are achieved.

Experience in leading teams without direct authority.

Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint. Effective presentation skills.

Will consider remote locations for:

Responsible for global process and the associated policies and procedures.

Master's degree in Mechanical Engineering, or Engineering Management

Minimum 5 years of experience in Engineering, showing increasing levels of responsibility.

Experience with design, installation and commissioning of complex systems that meet regulatory and industry standards.

Proven knowledge of EDMS, AutoCAD, and MS Office, Maximo, etc.

Ability to manage, balance, and prioritize multiple projects.

Demonstrated strong written and verbal communication skills; able to present complex data relationship in concise and straight forward presentations.

Seek out, recommend, and leverage recent technology in the areas of traceability, cold chain compliance, and specification management.

Manage the day-to-day execution of food traceability from supplier to restaurant; managing product removals when they are necessary.

Manage the team responsible for real-time monitoring of food quality reports from restaurants.

Manage supplier label compliance for traceability.

Manager, FSQA, Traceability & Quality Systems

Develop and maintain Chipotle Mexican Grill’s Food Safety and Quality Systems on digital platforms.

Proven knowledge of pharmacovigilance requirements strongly preferred.

Strong leadership skills, including experience of leading project teams.

Participate in both departmental and cross-functional meetings and initiatives to increase awareness, education, training, and leadership for patient safety/pharmacovigilance compliance.

Experience with Medical Devices strongly preferred.

Experience supporting regulatory inspections preferred.

Knowledge of QMS and continuous improvement methodologies

Proven experience as a Program Manager or in a similar project management role within a creative agency, product, or design department

Strong leadership and team management skills, with the ability to motivate and inspire creative teams

Proficient in project management tools and software to streamline workflows and track project progress

Lead and manage the end-to-end execution of projects, ensuring adherence to timelines, budgets, and quality standards

Foster a collaborative and positive team environment, promoting effective communication and knowledge sharing

Demonstrated ability to successfully manage multiple projects simultaneously, prioritizing tasks effectively and meeting deadlines

Experience working with stakeholders, Product & Engineering Managers to keep everyone aligned.

Ability to go beyond training to engage with technical teams with project management as needed

Establishes, develops, and sustains skills matrices for an entire business line.

Collaborates with operations leaders, subject matter experts, and training leaders to determine relevant skill sets and their organization.

Works with cross-functional teams to drive successful implementation of skills matrices.

Discerns software development requirements and proficiently communicates them to the development team.

Interact with quality and site management on the performance of quality systems.

Interact internally and externally with quality and site management to report on the performance of the quality system.

Demonstrate the ability to incorporate sound risk management fundamentals in the establishment of QMS

Maintain current knowledge of national and regional regulations regarding QSR, ISO, MDD, and quality assurance issues as they impact PSG QMS.

Minimum of 15 years’ experience in multinational pharma/biopharma organizations, covering multi-site quality systems, and quality operations roles with global experience.

Experience in strategy development and deployment, organisational change, and business improvement.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.

Equivalent combination of education and experience acceptable

Provide support for activities using the electronic Deviation and CAPA management systems

Review of SOPs, Work Practices and other types of documents as required. Performs supplemental investigations/projects as required by management.

Act as primary link to other CTDO sites to ensure Deviation and CAPA management process is properly implemented and consistent

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

Document quality issues and performance measures for management review

Ensure compliance and understanding of quality requirements

Manage special projects and make recommendations as appropriate

Perform other duties and responsibilities as assigned

Excellent computer and presentation skills

Strong business development, organization, analytical and problem-solving skills

Must be a team player with great interpersonal and communication skills; time-management

Requires eight to ten years of experience based on consistently demonstrated capabilities

Technical skills may include experience with one or more of:

Delegate work to other less experienced engineers and provide coaching / mentorship

Experience in Spring Boot, Node.js, RestAPI’s, React.js, and ActiveMQ, RabbitMQ, Kafka or any

Knowledge of web-based platforms such as RESTful APIs, Gateway access, Oauth2