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Penumbra, Inc. · 2 months ago

Quality Manager (Inspection)

Alameda, CA

Full-time

Onsite

Senior Level, Lead/Staff

$120K/yr - $185K/yr

8+ years exp

Penumbra is a global healthcare company focused on innovative therapies. The Quality Manager (Inspection) oversees all inspection activities for incoming materials and in-process products, ensuring adherence to quality standards and regulatory compliance.

Medical Device

H1B Sponsor Likely

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

Regular, reliable attendance onsite

Perform other work-related duties as assigned

Qualification

FDA QSRs knowledgeISO standards knowledgeQuality Management SystemSupervisory experienceData analysis experienceMicrosoft Office proficiencyTechnical writing proficiencyProblem solving skillsLeadership skillsInterpersonal communicationAttention to detail

Required

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

Excellent problem solving, organizational and leadership skills

Excellent oral, written, and interpersonal communication skills required

Thorough knowledge and understanding of FDA QSRs, ISO standards, and the MDD

Knowledge of sterilization requirements for medical devices

Knowledge of controlled environments for medical devices

Proficiency with Microsoft Office (Word, Excel, Access, Power Point, Power BI, and Project)

Technical writing proficiency (e.g., protocols, analytical reports, ECOs, SOPs, Work Instructions, Inspection Methods)

Strong analytical and decision-making skills and a results-driven approach

Experience in SPC, process capability, statistics and data analysis

Experience in Design Control and Process Validations

High degree of accuracy and attention to detail

Preferred

4+ years of experience in a Supervisory role desired

ASQ certifications for CQE, CQA, CQM, or equivalent preferred

Benefits

Medical

Dental

Vision

Life

AD&D

Short and long-term disability insurance

401(k) with employer match

An employee stock purchase plan

Paid parental leave

Eleven paid company holidays per year

A minimum of fifteen days of accrued vacation per year, which increases with tenure

Paid sick time in compliance with applicable law(s)

Company

Penumbra, Inc.

Glassdoor3.3

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.

Founded in 2004

Alameda, CA, US

1001-5000 employees

http://www.penumbrainc.com

H1B Sponsorship

Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (36)

2024 (42)

2023 (46)

2022 (43)

2021 (36)

2020 (26)