Project Manager, Quality & Compliance at Penumbra Inc

Alameda, California, United States

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor's degree, preferably in life sciences or engineering, with 5+ years of quality management systems experience in a regulated medical device or pharmaceutical environment, or equivalent combination of education and demonstrated experience
Proven experience with eQMS platforms, such as MasterControl
Ability to manage multiple, complex priorities within demanding timeframes with precision and accuracy
Experience designing and implementing continuous improvement initiatives aligned with regulatory and business needs
Proven ability to influence stakeholders and drive adoption of new ideas and processes
Medical device, pharmaceutical, biotech, or other regulated industry experience desired
Strong oral, written, and interpersonal communication skills

Responsibilities

Evaluate and proactively identify updates needed within the existing QMS processes, policies, and procedures to meet evolving regulatory requirements and business needs
Partner with business stakeholders to identify process challenges and develop solutions, including eQMS driven solutions
Collaborate with stakeholders to gather critical information for prioritizing project requests
Resolve ambiguous requirements through structured discussions, and translate them into clear, comprehensive business requirements documents aligned with stakeholder objectives
Partner with cross-functional teams and act as a driver for collaboration, ensuring alignment across departments and fostering a cooperative environment to achieve project goals
Establish clear roles and responsibilities with cross-functional team members to promote accountability, streamline workflows, and ensure successful project execution
Design and document process workflows that align with regulatory requirements and business objectives
Lead cross-functional efforts with Subject Matter Experts (SMEs) to assess, revise, and implement quality processes and procedures
Design and manage complex project plans, setting strategic milestones, allocating resources, deliverables, and compliance activities to meet stakeholder expectations
Independently lead and manage QMS improvement initiatives from concept through execution, ensuring successful project delivery that aligns with regulatory compliance requirements, internal policies, and industry standards
Maintain oversight to ensure all projects adhere to relevant regulations, internal quality policies, and standards throughout all project phases, mitigating compliance risk
Serve as a key contributor to audit readiness, prepare for, and participate in external audits by regulatory authorities
Establish clear communication channels for reporting project status, to ensure visibility of project progress, risks, and key decisions to both the project team and management
Influence stakeholders through data-driven insights and compliance knowledge expertise, to ensure project alignment, resolution of compliance gaps, and seamless execution
Collaborate with cross-functional leaders to drive quality initiatives, communicate project progress, implement risk mitigation strategies, and ensure the effectiveness of the QMS
Keep management stakeholders informed on key compliance efforts and continuous improvement activities

Skills

Project Management

Quality Management System

QMS

Regulatory Compliance

Process Improvement

Cross-functional Collaboration

Risk Mitigation

Stakeholder Management

Business Requirements

eQMS

Penumbra Inc

Develops medical devices for vascular conditions

About Penumbra Inc

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.

Alameda, CaliforniaHeadquarters

2004Year Founded

$116.7KTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Parental Leave

Paid Vacation

Paid Sick Leave

Paid Holidays

Risks

Recent layoffs in the Immersive Healthcare division may indicate financial strain.

The EMBOLIZE trial could divert resources from core product lines.

Regulatory challenges in Europe may impact sales of new products like BMX81 and BMX96.

Differentiation

Penumbra offers a comprehensive range of neuro and peripheral vascular devices.

The company focuses on innovative solutions for stroke and neurovascular disease treatment.

Penumbra's global presence spans North America, Europe, Asia, and Australia.

Upsides

Growing demand for minimally invasive procedures aligns with Penumbra's product offerings.

The global neurovascular devices market is projected to grow at 8.5% CAGR until 2030.

Penumbra's European launch of BMX81 and BMX96 expands its market presence.

Land your dream remote job 3x faster with AI

Try Jobo Free