Quality Control Inspector

Biotronik; Tustin (CA); On-site; USD 72,000 - 96,000; Full time

Benefits offered by this job

Health insurance

Bonus program

Paid time off

Retirement plans

Job summary

BIOTRONIK EP CRC in California is seeking a Quality Control Inspector to ensure strict adherence to CRC EP quality systems. This role collaborates with Manufacturing and Engineering to perform FAI inspections, in-process and final testing, and document control across GDP processes.

Superior attention to specification details and problem-solving skills are required. The position focuses on supporting regulatory readiness for cardiac catheter manufacturing with a strong emphasis on data analysis,

Qualifications

• High school diploma required; bachelor’s degree preferred.
• Experience with quality control inspection and measurement techniques.
• Knowledgeable of GMP and ISO 13485 preferred.
• At least 5 years of QC inspector experience in class III catheter manufacturing.

Responsibilities

• Perform First Article Inspection (FAI) of parts and conduct visual, mechanical, electrical, and dimensional inspections.
• Support the receiving process and verify labels against artwork and specs.
• Collect incoming material documents with procurement/engineering as needed.
• Inspect in-process and final assemblies and verify tolerances and specifications.
• Perform electrical testing (Hi-Pot, insulation) and mechanical testing (Tensile, Peel).
• Approve finished products and coordinate rework as required.
• Record inspections and maintain DHRs in compliance with GDP practices.
• Compile quality data in Excel and support investigations and CAPA.

Skills

Quality control

Inspection techniques

Measuring devices

GMP knowledge

ISO 13485 knowledge

Communication skills

Education

High school diploma

Bachelor's degree preferred

Tools

Microsoft Excel

Measuring instruments

Job description

Career Opportunities: Quality Control Inspector (62662)

BIOTRONIK is one of the leading manufacturers of cardio and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

California Research Center Electrophysiology, Inc (CRC EP, Inc.),a Biotronik business unit located in Tustin, CA, develops pulsed-field cardiac ablation (PFA) technologies. The team has recently completed the First-in-Human clinical trial which validated the company's PFA technology for treatment of atrial fibrillation. The team is embarking on preparing the technology for regulatory approvals followed by commercial release in respective territories. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

We are seeking a QC Inspector role is a critical role ensuring the planning and execution within CRC EP catheter manufacturing group. This role is integral with manufacturing engineering and quality control. This is accomplished by performing receiving inspections including First Article (FA) inspection, in-process and final inspection, writing inspection protocols and reports, working closely with manufacturing engineering to develop material specs and inspection criteria, working closely with Quality to ensure compliance with CRC EP QMS.

Key Responsibilities

• Perform First Article Inspection (FAI) of parts according to CRC EP procedures and conduct visual, mechanical, electrical, and dimensional inspections of incoming materials.
• Support the receiving process for incoming parts and verify label accuracy against approved artwork, component specifications, and documentation.
• Work with CRC EP procurement and/or engineering to collect incoming material documents when needed.
• Conduct visual, mechanical, electrical, and dimensional inspections of incoming material, in-process product, labeling, and final assemblies.
• Conduct electrical testing (continuity, insulation resistance, Hi-Pot) and mechanical testing (Peel Testing, Tensile Testing).
• Inspects in-process and final inspection of production materials by confirming specifications, conducting visual and measurement tests, communicating required adjustments to Manufacturing Manager or Engineering.
• Approves finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work, and confirming re-work.
• Follows verbal and/or written instructions such as lot history record, work instruction, and process specifications at the direction of Manufacturing Manager or Engineering in completing a variety of inspection tasks.
• Performs product release according to lot release requirements.
• Records inspections and reviews DHRs for completeness, correctness, and compliance with GDP practices.
• Compile, maintain, summarize, and analyze inspection and quality data using Microsoft Excel and other electronic systems to support investigations, supplier performance monitoring, and continuous improvement activities.
• Work quickly and efficiently to achieve targeted goals as set by the production schedule
• Keeps measurement equipment operating by following operating instructions and calibration requirements and calling for repairs.
• Support internal and external audits, as necessary.
• Initiates Nonconforming Material Reports (NCMR) on nonconforming / unacceptable materials.
• Participate in CAPA processes.
• Maintains safe and healthy work environment by following standards and procedures and complying with legal regulations.
• Work collaboratively with Engineers and Manufacturing teams to resolve quality issues.

Your Profile

Education Requirements

• High school diploma required; bachelor's degree preferred
• Experience with quality control inspection and measurement techniques
• Experience with measuring devices such as meters, gauges, computers, calipers, multimeter and other measuring instruments
• Knowledgeable of Good Manufacturing Practices (GMP)
• Working experience with ISO 13485 is preferred
• At least 5 years of prior QC inspector experience in class III catheter manufacturing

Experience Requirements

• Good written and verbal communication skills
• Good organization skills
• Basic math skills
• Basic computer skills including Microsoft Word and Excel
• Analytical skills

Physical and Travel Requirements

The physical demands described within this job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer for extended periods of time and communicate with co-workers, suppliers, auditors, and external regulatory stakeholders.
• Must be able to work a minimum of 40 hours per week.
• Must be able to work onsite at the Tustin, CA facility.
• Must be able to travel domestically up to 5% of the time.

Work Location

This role is based at our Tustin, CA office.

This position is performed primarily in a professional office environment and requires regular use of a computer, standard office equipment, quality system documentation, engineering and regulatory records, and virtual communication tools. Work involves extended periods of sitting, reading, writing, typing, document review, and participation in meetings, with occasional work in laboratory, manufacturing, supplier, audit, or controlled environments to support quality engineering, validation, supplier management, and regulatory activities. The employee is expected to maintain confidentiality and comply with applicable company policies, quality system requirements, and regulatory standards. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

What We Offer

• Competitive base salary, with a corporate annual bonus.
• Opportunity to shape quality strategy for breakthrough cardiac technologies.
• A collaborative, mission-driven environment where your expertise has immediate impact.

BIOTRONIK EP CRC is dedicated to fair and equitable compensation practices. The base salary range for this position is $72,000 - $96,000 per year, based on experience and qualifications. In addition to base salary, BIOTRONIK EP CRC offers a bonus program and comprehensive benefits package, which includes health insurance, retirement plans, paid time off, and other perks.

Location: Tustin, CA | Working hours: Full-time | Type of contract: Unlimited

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.