Quality Operations Program Manager Jobs

·Working knowledge of quality management system standards (ISO 9000)

Develops, maintains, and revises Quality Management System (QMS) procedures and metrics complimentary to company policies and goals

Documents quality management training programs for employees

·Management and supervisory over quality department employees and duties

Works in conjunction with engineering and production to review new product development to assure customer requirements have been met

Manages, and reports results of internal/external audits of the QMS and defines expectations by continued communication with customer

Strategic project management skills - with a strong emphasis on regulatory projects and budget experience

Issues monthly regulatory updates to the LS-QT Management Team

Ideal candidate would have 5 years or more of managerial experience

Manage and analyze complex data from multiple sources

Have functional knowledge of GMP, ISO 13485, MDSAP impact on Field Service processes and operations

Responsible for the documentation and reporting requirements of all special project activities

Participating and leading cross-functional teams. Communicating with management on the status of projects including resource gaps and needs.

At least 5 years previous experience in Managed Care and Medicare is strongly preferred.

Remote - work from home.

Understanding CMS/State program requirements and researching the external environment related to Quality improvement and innovations.

This position has no supervisor responsibilities

To perform this job successfully, an individual should have expert working knowledge of Gmail and Google Workspace.

Strong analytical, problem-solving, and project management skills.

Strong knowledge of FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations

Develop training materials to ensure that Quality Operations employees meet the requirements of the company and clients.

7+ years of Quality Assurance experience in a GXP related field within the biotechnology, biologics, or pharmaceutical industry

Excellent interpersonal, verbal, and written communication skills are meaningful in this collaborative work environment

Experience reviewing and releasing Final Product preferred

Strong knowledge of quality improvement methodologies, regulatory standards, and best practices in healthcare quality management.

Develop and implement comprehensive quality improvement programs that align with organizational goals and regulatory requirements.

Collaborate with cross-functional teams to identify and address areas for improvement, including patient safety, clinical outcomes, infection prevention, and patient experience.

Coordinate and conduct regular quality improvement meetings, providing education and training to staff members on quality improvement methodologies.

Stay up-to-date with industry trends and best practices in quality improvement, sharing knowledge, and implementing new strategies as appropriate.

Minimum of 5 years of experience in quality improvement, preferably in a hospital or healthcare system setting.

8+ years program/project management experience with demonstrated success enabling support experience excellence in an enterprise support environment

Build, manage, and execute on project plans. Oversee and adjust priorities based on business needs.

Experience coaching and cultivating a culture and community of Quality

Strong cross collaboration experience and ability to influence without authority

Solid communication skills; ability to concisely package and present program status, findings and insights in PowerPoint

Lean/Six Sigma Green Belt+, PMP certifications

8 years of experience in program management (leading cross-functional projects/programs).

Bachelor's degree in a technical field, or equivalent practical experience.

5 years of experience in a leadership role with/without direct reports.

Experience with root cause techniques and corrective action implementation.

Experience with design of experiment (DOE).

Experience with hardware development processes.

Management and oversight of the QIM performance dashboards, work plan progress and forecasting.

Promotion of opportunities for participation in metric-focused technical assistance offered by OHA or other organizations.

Education, Certificates, Licenses: Bachelor’s Degree required. Graduate degree preferred.

Lead, develop, and implement CCO Quality Metric multi-year work plans to support continuous quality improvement and achieve strategic goals.

Collaborate with and work cross functionally to influence, lead and promote change that drive continuous quality performance improvement.

Accountable for ensuring responsible parties are improving QIM performance both internally and externally.

Work with the Systems Engineering team to to design simulation tests and ensure sufficient coverage for our systems requirements

AV industry experience - 3+ years of experience in autonomous vehicle/robotics industry in a software quality operations role (simulation experience preferred)

You are a critical thinker with strong root cause analysis skills

You have strong leadership and presentation skills

Great communicator with experience writing clear, concise, and detailed communication

Nice to have: Autonomous vehicle software triage experience

3+ year experience managing teams of people in high volume manufacturing setting

BS or MS in Business or Technical discipline and/or evidence of exceptional experience

Communicate clearly using excellent written and verbal skills

Strong organization skills with meticulous attention to detail

The Role: Associate Manager, Quality Operations - Gigafactory Nevada

Build a strong, motivated Quality Operations team capable of consistently delivering high-quality performance

Experience: Five years of experience in developing, implementing, administering, and evaluating programs, to include responsibility for regulatory or quality management.

Mental and Emotional Requirements: Manages stress appropriately.

Education: Bachelor’s Degree in Science, Nursing, Healthcare, Business, or a directly related field.

Certification(s): Specific certification(s) may be required depending on the position.

Prepares presentations and training materials for public education and awareness programs; delivers presentations at conferences, public meetings, and seminars.

Mental and Emotional Requirements: Independent discretion/decision making.

Apply solid program and project management skills.

Bachelor’s degree or equivalent experience in Business or Quality Management, Engineering, Math, or another related Life Sciences field degree.

Change Management and Project Management best practices in addressing quality improvement and regulatory compliance needs.

Project management and process mapping software, Microsoft tools (SharePoint, Excel, Visio, PowerPoint).

· Project cost analysis and management.

Conducts quality and regulatory risk assessments, and analyses of impacts and cost-benefits to promote programs and justify changes.

3+ years of project or program management experience

Familiarity with GitHub, including branch management and pull requests

Build automation tests for hands-on challenges, manage the execution of those tests, and interpret results for quality assurance.

Excellent verbal and written communication skills

Experience writing code (any language)

Salesforce platform experience as an administrator or developer

3 – 5 years of experience in public health, healthcare operations or project management preferred.

Interpersonal skills (e.g., partnering, conflict management, mentoring), and the ability to interact with most levels of business, technical and end users.

Participating and leading cross functional teams. Communicating with management on status of projects including resource gaps and needs.

Strong leadership, project management and/or business analysis background.

Understanding CMS/NYS program requirements and researching the external environment related to Quality improvement and innovations.

Prior experience with leading/facilitating cross-functional teams