Sr. Document Control / Quality Assurance Specialist (Temporary)

The primary function of this position is to provide Document Control support under minimal supervision for mid-stage medical device development projects and quality systems, as well as Quality Assurance/Quality Engineering support as needed. This is a temporary position for six months, starting in February 2025.

Your Responsibilities

• Generate and log Document Change Orders (DCO).
• Maintain all Document Control paper files, including project Design History Files (DHF).
• Provide and document appropriate document numbers per internal Standard Operating Procedure (SOP).
• Assist in creating and maintaining Product Complaint records.
• Ensure all appropriate document revisions are maintained.
• Maintain and coordinate Calibration and Preventative Maintenance of CRC equipment.
• Support internal, external and supplier audits as part of the CRC Audit Team.
• Support Receiving inspection of materials.
• Support maintenance of supplier files and supplier qualification and re-qualification activities.
• Support Quality activities (e.g., CAPAs, NCMRS, RMAs, etc.) as needed.

Your Profile

Education / Experience Requirements

• 5 years’ experience in Medical Device Document Control and/or Quality Assurance.
• Proficient in use of MS 365 (Word, Excel, PowerPoint).
• Experience in use of Dropbox, Teams/SharePoint.
• Well organized, able to multitask.

Additional Preferred Knowledge, Skills and Abilities

• Bachelor’s degree
• Experience with Complaint Handling is a plus.
• Experience with purchasing, incoming inspections, and inventory control of parts.
• Working knowledge of ISO 13485:2016 is a plus.

Physical and Travel Requirements

The physical demands described within this job description 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.
• Must be able to work onsite at our Tustin, CA facility. No relocation support will be provided.
• Must be able to travel domestically, less than 10% of the time.
• Must be able to work a minimum of 40 hours / week. Minimum to no work-from-home opportunity.

Work Location: The location for this position is onsite, and will work out of our Tustin, CA office.

Start Date: February 2025

Duration: Temporary, 6 months

About Us

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.

EEO Commitment:

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. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.

This temporary opportunity offers the chance to gain valuable experience in medical device development and quality systems in a dynamic environment. We look forward to hearing from you!