QA Supervisor - DHR Review at Penumbra Inc

Roseville, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor's degree with 2+ years of experience, or equivalent combination of demonstrated education and experience
Proficiency with Microsoft Office (e.g., Word, Excel, Access, PowerPoint, etc.)
Demonstrated working knowledge of Medical Device regulations
Prior supervisory experience preferred
Solid problem solving, decision-making, and supervisory skills
High degree of accuracy and attention to detail
Excellent organizational skills with ability to prioritize assignments while handling various assignments simultaneously
Willingness and ability to work on site
Ability to lift and move up to 25 pounds
Ability to move between buildings and floors
Ability to remain stationary and use a computer or other standard office equipment for extended periods
Ability to read, prepare emails, produce documents and spreadsheets
Ability to move within the office and access file cabinets or supplies as needed

Responsibilities

Select, manage, train, and develop staff; establish objectives and assignments; provide ongoing feedback through performance reviews and development plans
Manage the scheduling of DHR Reviewers for coverage, prioritization, and workload
Coordinate with internal customers to establish prioritizations and work through discrepancies
Communicate and train internal customers when processes are changed
Complete DHR Review when needed
Analyze and generate trending data to support system effectiveness
Evaluate procedures and work instructions for processing improvements and implement changes as necessary
Support Quality System processes during internal and external regulatory audits
Proactively seek system improvements while maintaining compliance to applicable requirements
Communicate Quality System issues to upper management, presenting solutions as appropriate

Skills

Microsoft Office

Excel

Medical Device Regulations

DHR Review

Supervisory Skills

Problem Solving

Quality Systems

Regulatory Audits

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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