Quality Manager (Inspection) at Penumbra Inc

Alameda, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor's degree with 8+ years of relevant experience in the fields of quality, biomedical, life sciences, physical sciences, engineering, or an equivalent combination of education and experience
4+ years of experience in a Supervisory role desired
Excellent problem solving, organizational and leadership skills
Excellent oral, written, and interpersonal communication skills
Regular, reliable attendance onsite (swing shift, Monday - Friday, 4:00pm - 12:30am in Alameda)

Responsibilities

Manage Quality Supervisors across different QC areas from incoming inspections to in-process inspections
Champion the reduction of GMP/GDP related issues
Assist Engineering with Quality Improvement projects to drive down product defects
Own inspection related NCRs, CAPAs and prevent recurrence
Drive MQI/VR procedural updates with Engineering to improve inspections
Drive equipment/fixture needs with EQ or Engineering for inspection efficiency improvement
Analyze time studies, complete utilization files, and determine inspection staffing needs
Ensure the implementation of inspector certification and training programs, along with necessary line layout and workspace needs to support committed build plans
Provide inspection and training support for NPIs or site transfer activities
Collaborate, review and own ECOs, DAs and Material Actions
Maintain, analyze, and trend Quality Inspection dept metrics
Attend and actively participate in master scheduling meetings, addressing and escalating line issues as needed. Identify themes and take appropriate actions to rectify the issues
Address, contain, and document non-conformances, identify root causes, and implement solutions. Take ownership for inspection related non-conformances and ensure they are managed with urgency
Ensure work orders are processed in a timely manner, proactively identifying and resolving any delays that impact committed build plans
Collaborate with Production, Engineering and/or Planning on delayed work orders to determine corrective actions needed to mitigate and prevent backorders
Maintain an environment of continuous improvement, lean manufacturing and efficiency through lean principles, employee coaching, kaizen events, and KPI monitoring
Responsible for interfacing with the FDA, State Agencies, and notified bodies during routine ISO audits
Serve as the subject matter expert (SME) for QC areas and understand inspection processes in accordance with documented procedures
Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans
Adherence to all local, state and federal laws which include but not limited to wages and hours
Ensure that health and safety guidelines are followed
Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
Ensure the department follows the QMS, regulations, standards, and procedures
Perform other work-related duties as assigned

Skills

GMP

GDP

NCR

CAPA

ECO

MQI

NPI

QC Inspection

Root Cause Analysis

Time Studies

Metrics Analysis

Training Programs

Regulatory Compliance

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.

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