Position: Director/Sr. Director, Quality Job 2479
Location: Fort Worth/Dallas Metro Area, TX (in-office 5 days a week)
Compensation: Title and Compensation are Based Upon Experience
Summary: This position reports to the CEO and is responsible for leading the development and implementation of quality and regulatory programs in accordance with the company's Quality Policy & Quality Management System.
Essential Functions:
Act as the company's Quality Management Representative.
Ensures the company's Quality Management System is effective, efficient and compliant to applicable ISO standards, FDA regulations and to customer requirements for developing , and manufacturing and distributing Class I & II medical devices.
Analyzes , evaluates, and presents data concerning quality assurance and regulatory affairs related to current and future products to other members of the management team.
Leads quality management review activities and evaluates trending data to identify inputs to the improvement process.
Acts as a member of the company's management team.
Provides leadership to Quality Assurance/Regulatory department activities.
Manages communication with the FDA and other relevant regulatory and compliance bodies.
Supports product development activities, including DHF development , design controls, and risk & hazard analysis (i.e. FMEA).
Responsible for non-conforming material and customer complaint investigations and ensures corrective/preventive action (CAPA) activities are implemented and verified.
Reviews, evaluates and approves quality processes, procedures and policies, and ensures all operations are performed in accordance to SOP, FDA, CDMR , QSR (GMP) and ISO guidelines.
Leadership of the quality laboratories including finished product testing and inspection, and OOS investigations .
Directs and coordinates (as Quality Management Representative) internal, vendor, customer, and regulatory audits.
Responsible for the identification and issuance of medical device/vigilance reports to the appropriate regulatory authorities and execution of product recall activities.
Leads the Regulatory function for the site, including licensing and 51Ok submission activities.
Leads the supplier quality function for the site, including evaluation, assessment , and performance monitoring of suppliers .
Leads the training, document control, and records functions for the site.
Reviews technical issues and processes for various departments and provides recommended solutions when applicable.
Provide quality oversight of production processes, including calibration, validation, lot release, and product stability activities.
Maintains and monitors product sterilization processes, including pre/post sterilization and sterility testing activities, audits, and validations.
Ensures quality staff/team is completing tasks and activities in a timely manner and in accordance with applicable work instructions and quality procedures.
Requirements:
Bachelor's degree in Science or Engineering is required.
Minimum of 1O years of experience in FDA/GMP facility within the medical device/pharmaceutical manufacturing industry. Minimum of 5 years direct experience in QA/QC function.
Proficient in regulatory requirements for ISO 13485, 21 CFR Part 820, and CDMR.
Experience with sterilization (Gamma and EtO) and packaging standards , requirements and processes.
Experience with data analysis tools, such as: Minitab, descriptive & inferential stats, DOE and Six Sigma.
Excellent verbal and written skills for communicating internally and externally (to customers, vendors, regulating bodies, etc.)
Proficient in the use of office software including MS Word, Excel, Project and ERP/MRP systems.