Sr. Quality Compliance Engineer- Shockwave Medical

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow.

About the role

We’re hiring for a Senior Quality Compliance Engineer at Shockwave Medical in Santa Clara, CA. This role maintains quality compliance, assists in the release of final product, and supports systems such as Receiving Inspection, NCR, Supplier controls, Competency Assessment, and Audit activities. The position also provides quality engineering support for manufacturing, including calibration systems and environmental monitoring of cleanrooms.

Responsibilities

• Review Production and Sterilization Records and release of Final Product to inventory.
• Review Production Records for accuracy, good documentation practice, and compliance with Manufacturing Instructions.
• Compile and monitor process control data.
• Review sterilization records and lot release test data to ensure product can be released to inventory.
• Ensure non-conformances/deviations and rework orders are resolved.
• Manage Equipment and Tool Calibrations, including implementation and validation of new Equipment Control software.
• Implement IQ and Calibration requirements in accordance with manufacturer recommendations and internal requirements.
• Harmonize equipment specifications, Installation Qualification, and Calibration requirements.
• Coordinate with calibration vendors and equipment manufacturers to ensure all tools and equipment are calibrated prior to their due dates.
• Assess risk and product impact in the event of an out-of-tolerance condition and resolve the situation cross-functionally.
• Work with the Manufacturing Engineering group to ensure Preventive Maintenance is performed as scheduled.
• Work with R&D and Manufacturing Engineers to draft and maintain Incoming Inspection Plans.
• Identify and implement Incoming Inspection measuring equipment and train QA inspectors on such equipment.
• Ensure periodic Environmental Monitoring of cleanrooms is scheduled and performed by an approved supplier.
• Review Environmental Monitoring test results to ensure compliance and address non-conformances.
• Coordinate Bioburden/Quarterly Dose Audit builds and ensure sterility testing is performed per schedule.
• Review test data to ensure validated sterilization parameters remain valid.
• Perform ongoing review of Janitorial and Pest Control Records.
• Manage the Technician and Assembler competency program using a risk-based approach.
• Initiate and maintain supplier files on the Approved Supplier List.
• Gather and update information to ensure supplier files are current and compliant with Shockwave Medical Supplier procedures.
• Track and manage SCARs (Supplier Corrective Action Requests) from initiation through closure.
• Compile quality metrics for trending purposes, including NCRs, CAPAs, SCARs, and Complaints.
• Identify additional data sets for trending to improve the Quality Management System (QMS).
• Assist with maintaining the NCR System, including participation in NCR review meetings and tracking NCR activities.
• Identify and implement NCR system continuous improvement activities.
• Assist with audit preparation activities and management of related “Audit Findings.”
• Participate in quality system activities and serve as a subject matter expert during internal and external audits.
• Coordinate audit-related activities (prepare documents, track requests, take notes, schedule meetings).
• Initiate, track, and implement audit findings to address non-conformances.
• Review DV&V or other test data sheets to ensure accuracy and compliance with protocols and procedures.
• Provide guidance to team members to ensure QMS and Regulatory compliance requirements are met.
• Work cross-functionally to track and ensure Quality Objectives published during Management Reviews are met.
• Support company goals, policies, procedures, QSR, and FDA regulations.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in a related technical discipline preferred.
• 4-6 years of related experience.
• Experience in the medical device industry is strongly preferred.
• Understanding of cGMP, FDA 820 QSR, and ISO 13485 or similar Quality Systems.
• Ability to understand and follow QMS Procedures (e.g., SOP and Test Methods).
• Proficiency in data compilation, analysis, presentation, and document writing.
• Excellent written and verbal communication skills.
• Experience with computer-based applications (MS Word, MS Excel, QAD).
• Strong time management skills and ability to multi-task in a fast-paced environment.

Skills

• Business Alignment
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail-Oriented
• Goal Attainment
• Human-Centered Design
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards

Pay

The anticipated base pay range for this position is $91,000.00 - $147,200.00.

Benefits

• Retirement plan (pension) and savings plan (401(k)).
• Long-term incentive program.
• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents).
• Holiday pay, including Floating Holidays – 13 days per calendar year.
• Work, Personal, and Family Time – up to 40 hours per calendar year.
• Parental Leave – 480 hours within one year of birth/adoption/foster care.
• Bereavement Leave – 240 hours for an immediate family member, 40 hours for an extended family member per calendar year.
• Caregiver Leave – 80 hours in a 52-week rolling period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.