Quality Manager (Inspection)

The Quality Manager (Inspection) oversees all inspection activities for incoming materials and/or in-process products, ensuring adherence to quality standards and regulatory compliance. This role is responsible for maintaining product quality, providing accurate quality records, and ensuring inspections are compliant with standard operating procedures. The Quality Manager works onsite in Alameda. This opening is for the swing shift, Monday - Friday, 4:00pm - 12:30am.

•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.

•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.

Additional qualifications:

•4+ years of experience in a Supervisory role desired

•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

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

•High degree of accuracy and attention to detail

 

•General office, production, inspection laboratories and controlled environment facilities.

•This is a people-manager position and requires working onsite 5 day a week.

•May have business travel from 0% - 15%.

•Travel to other Penumbra sites may be required.

•Potential exposure to blood-borne pathogens.

•Requires some lifting and moving of up to 25 pounds.

•Proficient in using computers for emails, training, reviewing procedures, etc.

•Must be able to communicate and exchange accurate information with various departments, and to upper management or senior leadership.

•Must be able to move between buildings and floors.

•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

•Requires some standing, walking, and sitting for extended periods at a workstation; use of bilateral dexterity to inspect for a period of time.

•Occasionally stoop, kneel, crouch, bend, or crawl.

•Must be able to remain stationary and use a microscope, cleanroom or laboratory equipment, or other standard office equipment, for an extensive period of time each day.

•Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

We offer a competitive compensation package plus a benefits and equity program, when applicable. 

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.