Quality Engineering Manager (Catheters)

General Summary

The Quality Engineering Manager is responsible for the management, development, implementation, and continuous improvement of the quality engineering functions.

Specific Duties and Responsibilities

• Management and engineering responsibilities for quality engineering, supplier management, calibration, environmental monitoring, and inspection (in-process and incoming). Technical expertise will revolve around the knowledge of the FDA Quality System Regulation (QSR), Medical Device Directive (MDD), and applicable ISO requirements for medical device manufacturers, and the ability to formulate company directives.
• Thorough understanding of practical quality engineering tools such as statistical data analysis, inspection techniques, product / process validation requirements, software quality assurance, designed experiments, reliability statistics, and solid decision making and problem-solving skills.
• Assure compliance with Quality Systems driving the manufacturing and inspection of products.
• Interface with the FDA, State Agencies, and notified bodies during routine ISO audits and FDA inspections.
• Direct management of engineers who support development, inspection, and manufacturing of products.
• Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *
• 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 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

Location and Pay:

Alameda, CA

$145,000 to $214,000

Position Qualifications

Minimum education and experience:

• Bachelor of Science degree with 4+ years of related experience in the fields of quality, biomedical, life / physical sciences, engineering, or equivalent combination of education and experience.

Additional qualifications:

• Experience in statistical analyses data analysis
• ASQ certifications for CQE, CQA, CQM, or equivalent.
• Thorough knowledge and understanding of FDA QSRs, ISO standards, and the MDD.
• Solid problem analysis and decision-making ability and leadership skills.
• Knowledge of sterilization requirements for medical devices.
• Knowledge of biocompatibility requirements for medical devices.
• Knowledge of environmental qualification and monitoring requirements for medical devices.
• Knowledge of product and process validations for medical devices.
• Computer literacy with preference to Microsoft Professional Office Suite, i.e., Excel, Word, Access, Power Point, and Microsoft Project
• Technical writing proficiency (e.g., protocols, analytical reports, ECOs, SOPs, Test Methods, procedures)
• CAD experience (AutoCAD 2000 or more recent)
• Basic tool, fixture, jig, and instrumentation understanding
• Practical knowledge in SPC, process capability, gage R&R, DOE, software quality assurance, electronic records, and risk analysis
• Analytical laboratory testing conditions, e.g., in vivo, in vitro

Working Conditions

• General office, laboratory, and cleanroom environments
• Business travel from 0% - 10%
• Requires some lifting and moving of up to 25 pounds
• 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.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

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 the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes 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, and paid sick time in compliance with applicable law(s).