Document Control Clerk

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients. Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

We are looking for a Document Control Clerk with passion for creating devices that save lives. The Document Control Clerk will be supporting various elements of the Quality System such as change control management, record keeping and training. If you have a proven track record of handling and managing those Quality System elements, we would love to talk to you.

RESPONSIBILITIES:

• Process documentation changes: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives.

• Audit changes for accuracy and completion. Review changes to ensure that language used in the change is adequate and in compliance. Ensure that changes are in a closed loop and all discrepancies (if any) are addressed and closed before the change is released.

• Provide clear and accurate communication to internal customers. Clearly communicate both verbally and in writing, with originators when discrepancies are found. Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies.

• Work with ECO Coordinator and originators in following-up, analyzing, and helping to resolve open ECO issues.

• Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals.

• Create and maintain change control metrics and reports.

QUALIFICATIONS:

• 1+ years document control experience with HS Diploma.

• Knowledge of medical device regulations and standards: ISO 13485 and FDA CFR.

• Strong working knowledge of Adobe Acrobat, and MS Office - especially Word, Excel, and Visio.

• Ability to work in a high volume fast paced environment with minimal instruction on routine work, and general instructions on new assignments.

• Ability to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule.

• Excellent written and verbal communication skills.

• Possesses strong organizational skills to manage and prioritize multiple tasks while meeting delivery dates.

• Knowledge of Electronic Document Management Systems is preferred.

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options

• 90% employer-paid medical, dental, and vision insurance

• Company-paid Basic Life Insurance

• 401(k) retirement plan (Traditional and Roth)

• Competitive Paid Time Off

• Paid Holidays

• FSA (Flexible Spending Accounts)

• HSA (Health Savings Account)

• Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $60,000 - $69,000 + Annual Bonus

Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job.