Quality Assurance Compliance Specialist

Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon:

1. http://www.bloomberg.com/video/vetigel-the-band-aid-of-the-future-stops-bleeding-instantly-PaIvLxjcS66F5IWO1SsKtA.html

2. http://www.ted.com/talks/joe_landolina_this_gel_can_make_you_stop_bleeding_instantly?language=en

Description

The QA Compliance Specialist is responsible for the continued development, maintenance, implementation, and improvement of Cresilon’s Quality Systems. Primary responsibility is to assess, monitor and improve compliance to regulatory standards by establishing routine and regular internal audits whose outcomes are reported to the Management. This position will serve as primary or alternate liaison to FDA and/or Notified Body officials during audits of the site.

Responsibilities

Participate in maintaining and monitoring FDA QSR 21 CFR 820 and ISO 13485 systems or other recognized regulatory standards for all markets in which our products are sold.

Establish processes and procedures to ensure compliance and improve the Quality Management System (QMS).

Investigate and diagnose customer complaints, quality issues, and non-conformances.

Develop, recommend and monitor corrective and preventive actions (CAPAs).

Establish and maintain a CAPA tracking and metric system.

Conduct post-market activities including complaints handling, internal investigations, MDR evaluations, and CAPA assessments.

Verify logs, databases, and other data to track and flag quality concerns and improvements.

Conduct internal audits, identify quality problems, and improve operational processes.

Document internal audits and other quality assurance activities and evaluate the adequacy of quality assurance standards.

Evaluate audit findings and implement appropriate CAPAs.

Coordinate and support on-site audits conducted by external providers.

Manage and timely report compliance issues to QA Management.

Prepare reports to communicate outcomes of quality activities to external parties.

Generate quarterly compliance report and areas of improvement for internal Management Review Meetings.

Draft, maintain and disseminate quality assurance policies and procedures.

Prioritize activities and provide recommendations for greatest effectiveness.

Perform quality functions including research, inspection, testing and analyze data.

Interact with all technical departments to investigate non-conformances and handle CAPAs.

Use creative problem-solving skills to identify, solve and/or improve process anomalies.

Work with suppliers, laboratories, customers, and other group members to assist with implementation and effectiveness of customer deliverables.

Review documents and records for accuracy and technical application of standards (ISO, AAMI, ASTM, and IEC).

Collect and compile statistical quality data.

Determine the need for change control and establish and maintain change control requests.

Actively develop, mentor, train and instill a site GMP culture.

Interface with all technical departments in a team-based environment to ensure process and product compliance with all relevant quality standards, including the formal qualification of personnel to perform investigations and audit activities.

Identify training needs and organize training interventions to meet quality standards. Support QA Management with department strategy development, objectives and goal setting, project prioritization activities.

Requirements

Working knowledge of ISO 13485 and FDA 21 CFR 820.

Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

5-8 years experience working in Quality Assurance / Quality Control in a medical device /pharmaceutical manufacturing environment.

Direct contact/interaction experience with the FDA, ISO registrars and other notified bodies is required.

Experience working with investigations, complaints, non-conformances, MDRs, change controls and CAPAs.

Auditor Certification such as ASQ CQA preferred.

Lean Six Sigma Certification preferred.

Bachelor’s degree in Science, Quality Assurance, Engineering or related scientific discipline.

Ability to generate and review protocols and Standard Operating Procedures (SOPs), which comply with internal and external standards.

Proficient in the use of MS Office.

Strong analytical, communication, negotiation, and change management skills.

Strong business insight, interpersonal and performance management skills for a highly global matrix organization and teams with diverse cultures and business practices is required.

Ability to interact with, influence, and lead cross-functional, cross-business unit teams is required.

Experience taking initiative with innovative ways to problem solve in a fast-paced, changing business environment is required.

Results driven, decisive, proactive, and responsive.

Benefits

Paid Vacation and Holidays (Minimum of 25 paid vacation days)

Medical, Dental, and Vision Insurance

Firm Paid Life and Short-Term Disability Coverage

401(k) Retirement Savings Plan