The Quality Manager (Inspection) is responsible for the management of all incoming and in-process inspections, including the correct maintenance of quality records and accurate inspections performed to current standard operating procedures.
The Quality Manager drives for continuous improvement and efficiency while maintaining quality standards at all times.
Specific Duties And Responsibilities
Manage incoming, in-process, packaging, labeling, and engineering development inspections, and inspection records.
Apply FDA Quality System Regulations (QSR), Medical Device Directive (MDD), and 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.
Supervise and motivate a team of Quality Supervisors, Inspectors and Specialists.
Develop and manage inspection schedules and shifts.
Select and maintain equipment necessary to complete inspections.
Determine and secure labor and material resources to meet Production plans/targets.
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.
Supervise and motivate a team of workers.
Review the performance of subordinates.
Identify and ensure that training needs are met.
Generate, review, or approve change orders.
Partner with Engineering on non-conformance investigations.
Maintain, analyze, and trend Quality Inspection dept metrics.
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
Ensure other members of the department follow the QMS, regulations, standards and procedures.
Perform other work-related duties as assigned.
Position Qualifications
Eight years of relevant experience in the fields of quality, biomedical, life / physical sciences, engineering, or equivalent. A combination of education and related experience will be considered.
Bachelor of Science degree preferred
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 for medical devices
Knowledge of environmental qualification for medical devices
Proficiency with Microsoft Excel, Word, Access, Power Point, Power BI and Project
Practical knowledge in Statistical Process Control, Process Capability, Gage R&R, DOE, software Quality Assurance, electronic records, and risk analysis
Strong knowledge of laboratory skills and analytical laboratory testing conditions, e.g., in vivo, in vitro
Ability to work day shift hours of 3 pm to 11:30 pm
Working Conditions
General office, production, inspection laboratories and controlled environment facility.
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.
Starting Base Salary Is: $99,000/year to $157,500/year + differential
Individual compensation will vary based on factors such as qualifications, skill level, competencies, work location and shift, and will increase over time based on meeting performance and business needs.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Penumbra, Inc. by 2x