Director Of Quality And Regulatory Affairs

Summary: Our client seeks a Director to administer the company's quality systems in accordance with customer requirements and supplier's capabilities. Facilitates the systems required to reach and maintain ISO, GLP, GMP and Quality compliance. This individual has the authority to provide the disposition of any product determined to be out of specification or unfit for use. Additionally, this individual has the authority to disapprove and cease any process determined not to be in compliance with specified procedures or protocol.

Essential Duties & Responsibilities:

20% Management:
•As a management representative, coordinate ISO, customer audits, and FDA inspections. As well as monitoring and reports KPI's related to the client's objectives.
•Analyzes department expenses to identify areas in which reduction or improvements can be made and allocates operating resources. Establishes plans and operates within an annual financial budget. Negotiates with and supports President/CEO to allocate resources required for completing all approved projects.
•Facilitates and reports on the status of Corporate Quality Metrics.
•Facilitates and reports of the status of the Quality Department
•Assists in the strategic planning and establishment of corporate goals and metrics.

40% Quality Control
•Develop, implement, and maintain quality systems, policies and procedures that ensure compliance to ISO 13485, cGMP, FDA, and other applicable standards.
•Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities. Develops a system for implementing and analyzing statistical data analysis to determine items; such as, capability, control, and compliance.
•Implements continuous improvement processes across all areas of business.
•Direct and participate in Document Control/Development functions and ensure all change orders are reviewed for QMS impact.
•Manage analysis and records of customer complaints, NMRs, RMSs, etc.
•Works with IT to verify and manage software programs affecting the QMS.
•Manages the client's risk management process to ensure the correct risk assessment.

10% Regulatory Affairs:
•Manage regulatory requests.
•Ensure compliance with regulations, laws and management requirements resulting from such changes.
•Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.

30% Supervision:

Responsible for the overall direction, coordination, and evaluation of Senior and Administrative personnel. Carries out supervisory responsibilities in accordance with the client's policies and applicable laws. Inclusive of interviewing, hiring, training; planning, assigning, and directing work; performance appraisals, recognition, and discipline of employees; addressing complaints and resolving problems.
•Communicates clearly, completely and with beneficial directives concerning performance expectations, productivity, and accountability.
•Develops employees for future advancement, where applicable
•Maintains employee retention.

Ensures equipment and systems adhere to safety requirements. Ensures employees use prescribed PPE. Advises employees of potential and actual hazards. Takes every reasonable precaution in the circumstances for the protection of employees. Completes HR-Employ-10 WC Employee Form at time of occurrences.

Required Qualifications:
•ASQ (American Society for Quality) and/or ISO certification as an Auditor, Biomedical Auditor or Six-sigma Green Belt.
•Bachelor's degree (B.A. or B.S.) in business, science, or a technical field.
•Minimum of 5+ years in regulatory and quality.
•Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to deal with problems involving several concrete variables in standardized situations. Ability to define problems, collect data, establish pacts, and draw valid conclusions.
•Able to multitask, prioritize and meet deadlines with strong organizational/follow-up skills, and attention to detail.
•Able to effectively present information and respond to questions from groups of managers, customers, and the public.
•Advanced computer skills, including statistical/data analysis, report writing skills, Microsoft Office, Excel, and the like.
•Able to effectively write reports, business correspondence, procedures, work instructions and procedure manuals. As well as reading and interpreting documents such as safety rules, operating and maintenance instructions, and procedure manuals.
•Ability to speak effectively before groups of customers or employees of the organization.
•Ability to work within a team and as an individual contributor in a fast-paced, changing environment including the ability to leverage and/or engage others to accomplish projects.
•Demonstrated team building and empathic leadership skills. Professional and positive approach, self-motivated, strong in team building, team player, as well as creative with the ability to work on own initiative. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
•Displays respect and sensitivity for all people regardless of age, color, gender, gender identity or expression, genetic information, national origin, race, religion, sexual orientation, protected veteran status, or because they are an individual with a disability or disabled veteran.
•Able to work well with others. Willing to assist others with their duties when needed to do so. Willingness to ask and answer questions. Listens to others with an open mind to differing opinions and ideas. Handles rapidly changing situations in a professional manner. Balances team and individual responsibilities. Contributes to a positive and productive "team" spirit. Self-confident and motivated.

Preferred Qualifications:
•ASQ (American Society for Quality) and/or ISO certification as a CMQ/OE, Six-sigma Black Belt and/or Quality Engineer (CQE)
•Master's degree (M.A. or M.S.) in a business, science, or a technical field with ten or more years of relevant experience.

Strong knowledge of QMS; particularly in ISO 13485:2003, cGMP, FDA, and other applicable standards.

Physical Requirements: (with or without the aid of mechanical) The physical requirements described here 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.
•Regularly required to stand, sit, walk, use hands to input, able to hear and talk.
•Position requires data entry and regular use of computer/keyboard/mouse for extended periods of time.
•Work demands concerted mental attention.
•Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
•Generally, works in an office environment, occasionally on the manufacturing floor. Travel is required. Work may require weekend or evening work.