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Sr. Manager, Quality Inspection
PenumbraUnited Statesfull_timeVerifiedPosted 25 May 2023
💰 $210,000/yr($155,000/yr – $210,000/yr)
About the role
Come join the Quality Control team at Penumbra, a company dedicated to saving lives.
In this role, you will develop, implement, and maintain quality system elements associated with but not limited to incoming and in-process inspections, including the correct maintenance of quality records and accurate inspections performed to ensure compliance to all applicable regulations, standards, and standard operating procedures.
Manage, develop, and supervise Quality Manager(s), Quality Specialist(s) and/or Quality Supervisor(s) supporting quality system elements.
Follow standards and procedures in analyzing situations or data from which conclusions can be readily obtained.
The Senior Manager for Quality Inspection strives for continuous improvement and efficiency while maintaining quality standards at all times.
Specific Duties and Responsibilities • Responsible for incoming, in-process, packaging, labeling, inspection records, and engineering development inspections. • Apply FDA Quality System Regulations (QSR), Medical Device Directive (MDD), an applicable ISO requirements for medical device manufacturers to inspection-related activities. • Formulate and carry out company directives based on knowledge of the Penumbra Quality System. • Develop, supervise, and motivate a team of Quality Managers, Supervisors, Inspectors and Specialists. • Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. • Select and ensure the maintenance of equipment necessary to complete inspections. • Review performance of inspection process outputs. • Determine and secure staffing and material resources needed. • Ensure compliance on Quality Inspections, Operations and Manufacturing Procedures.• Interface with the FDA, state agencies, and notified bodies during routine ISO audits and FDA inspections. • Ensure that health and safety guidelines are followed.• Review the performance of subordinates. • Identify and ensure that training needs are met.• Identify and implement continuous improvement efficiencies. • Develop goals and utilize appropriate metrics to monitor and make data driven decisions to strengthen department.• Champion the reduction of GMP/GDP related issues.• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. • Understands relevant security, privacy and compliance principles and adheres to the regulations, standards, and procedures that are applicable to the Company. • Ensure other members of the department follow the QMS, regulations, standards, and procedures. • Perform other work-related duties as assigned. *Indicates an essential function of the role
Position Qualifications • Bachelor of Science degree plus 10+ years of related experience in the fields of quality, biomedical, life/physical sciences or engineering or an equivalent combination of education and experience.• Solid analytical and decision-making ability and leadership skills • Experience in statistical and data analysis • ASQ certifications for CQE, CQA, CQM, or equivalent preferred • Thorough knowledge and understanding of FDA, QSRs, ISO standards, and the MDD • Knowledge of sterilization requirements and environmental qualification for medical devices • Strong oral, written and interpersonal communication skills • High degree of accuracy and attention to detail • Proficiency with MS Word, Excel, PowerPoint, Power BI, and MS Project • Technical writing proficiency (e.g., protocols, analytical reports, ECOs, SOPs, Work Instructions, Inspection Methods) • Practical knowledge in Statistical Process Control, Process Capability, Gage R&R, DOE, software Quality Assurance, electronic records, and risk analysis • Analytical laboratory testing conditions (e.g., in vivo, in vitro) • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Working Conditions • General office, laboratory, and cleanroom environments • Business travel from 0% - 10% • Potential exposure to blood-borne pathogens • Requires some lifting and moving of up to 25 pounds • The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. • Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
Annual Base Salary Range: $155,000 - $210,000We 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. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing
In this role, you will develop, implement, and maintain quality system elements associated with but not limited to incoming and in-process inspections, including the correct maintenance of quality records and accurate inspections performed to ensure compliance to all applicable regulations, standards, and standard operating procedures.
Manage, develop, and supervise Quality Manager(s), Quality Specialist(s) and/or Quality Supervisor(s) supporting quality system elements.
Follow standards and procedures in analyzing situations or data from which conclusions can be readily obtained.
The Senior Manager for Quality Inspection strives for continuous improvement and efficiency while maintaining quality standards at all times.
Specific Duties and Responsibilities • Responsible for incoming, in-process, packaging, labeling, inspection records, and engineering development inspections. • Apply FDA Quality System Regulations (QSR), Medical Device Directive (MDD), an applicable ISO requirements for medical device manufacturers to inspection-related activities. • Formulate and carry out company directives based on knowledge of the Penumbra Quality System. • Develop, supervise, and motivate a team of Quality Managers, Supervisors, Inspectors and Specialists. • Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. • Select and ensure the maintenance of equipment necessary to complete inspections. • Review performance of inspection process outputs. • Determine and secure staffing and material resources needed. • Ensure compliance on Quality Inspections, Operations and Manufacturing Procedures.• Interface with the FDA, state agencies, and notified bodies during routine ISO audits and FDA inspections. • Ensure that health and safety guidelines are followed.• Review the performance of subordinates. • Identify and ensure that training needs are met.• Identify and implement continuous improvement efficiencies. • Develop goals and utilize appropriate metrics to monitor and make data driven decisions to strengthen department.• Champion the reduction of GMP/GDP related issues.• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. • Understands relevant security, privacy and compliance principles and adheres to the regulations, standards, and procedures that are applicable to the Company. • Ensure other members of the department follow the QMS, regulations, standards, and procedures. • Perform other work-related duties as assigned. *Indicates an essential function of the role
Position Qualifications • Bachelor of Science degree plus 10+ years of related experience in the fields of quality, biomedical, life/physical sciences or engineering or an equivalent combination of education and experience.• Solid analytical and decision-making ability and leadership skills • Experience in statistical and data analysis • ASQ certifications for CQE, CQA, CQM, or equivalent preferred • Thorough knowledge and understanding of FDA, QSRs, ISO standards, and the MDD • Knowledge of sterilization requirements and environmental qualification for medical devices • Strong oral, written and interpersonal communication skills • High degree of accuracy and attention to detail • Proficiency with MS Word, Excel, PowerPoint, Power BI, and MS Project • Technical writing proficiency (e.g., protocols, analytical reports, ECOs, SOPs, Work Instructions, Inspection Methods) • Practical knowledge in Statistical Process Control, Process Capability, Gage R&R, DOE, software Quality Assurance, electronic records, and risk analysis • Analytical laboratory testing conditions (e.g., in vivo, in vitro) • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Working Conditions • General office, laboratory, and cleanroom environments • Business travel from 0% - 10% • Potential exposure to blood-borne pathogens • Requires some lifting and moving of up to 25 pounds • The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. • Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
Annual Base Salary Range: $155,000 - $210,000We 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. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing
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