Quality and Compliance Director
Summary: An opportunity awaits for a dedicated professional to fill the role of Quality and Compliance Director at our client's East Killingly, CT location. This position involves overseeing the company's quality systems to ensure compliance with customer requirements and supplier capabilities. The Director will also be responsible for maintaining ISO, GLP, GMP, and Quality compliance. They will have the authority to determine the disposition of products deemed unfit for use or out of specification, as well as disapprove any processes not compliant with established procedures.
Essential Duties & Responsibilities:
· Coordinate ISO, customer audits, and FDA inspections as a management representative. Monitor and report KPIs related to company objectives.
· Analyze department expenses to identify areas for improvement. Allocate operating resources and establish and operate within a yearly budget. Collaborate with the President/CEO on resource allocation for approved projects.
· Facilitate and report on the status of Corporate Quality Metrics.
· Facilitate and report on the status of the Quality Department.
· Assist in strategic planning and establishment of corporate goals and metrics.
40% Quality Control
· Develop, implement, and maintain quality systems, policies, and procedures to ensure compliance with ISO 13485, cGMP, FDA, and other relevant standards.
· Support and enhance company Quality Systems, fostering a culture of compliance. Develop a system for statistical data analysis to assess capability, control, and compliance.
· Implement continuous improvement processes company-wide.
· Manage Document Control/Development functions and review change orders for QMS impact.
· Manage analysis and records of customer complaints, NMRs, RMSs, etc.
· Collaborate with IT to manage software programs affecting the QMS.
· Oversee the client's risk management process and ensure accurate risk assessments.
10% Regulatory Affairs:
· Manage regulatory requests.
· Ensure compliance with regulations, laws, and management requirements resulting from changes.
· Stay informed about relevant regulations, standards, and guidance documents, including Medical Device Regulation (MDR) and other applicable standards/regulations.
Responsible for supervising and evaluating senior and administrative personnel. Carry out supervisory responsibilities in accordance with company policies and applicable laws. This includes hiring, training, planning, assigning and directing work, performance appraisals, recognition, discipline, addressing complaints, and problem-solving.
· Communicate performance expectations, productivity, and accountability clearly and effectively.
· Develop employees for future growth, where applicable.
· Promote employee retention.
Ensure compliance with safety requirements for equipment and systems. Enforce the use of personal protective equipment (PPE) by employees. Communicate potential and actual hazards and take necessary precautions to protect employees. Complete WC Employee Forms for incidents.
· Hold ASQ or ISO certification, such as Auditor, Biomedical Auditor, or Six-sigma Green Belt.
· Possess a Bachelor's degree (B.A. or B.S.) in business, science, or a technical field.
· Have a minimum of 5+ years of experience in regulatory and quality.
· Ability to interpret technical instructions and handle abstract and concrete variables in problem-solving. Proficiency with multitasking, prioritizing, and meeting deadlines. Strong organizational skills and attention to detail.
· Effective communication skills, both verbal and written. Proficient in report writing. Strong computer skills, including data analysis, Microsoft Office, Excel, etc.
· Hold ASQ or ISO certification, such as CMQ/OE, Six-sigma Black Belt, or Quality Engineer (CQE).
· Possess a Master's degree (M.A. or M.S.) in business, science, or a technical field with ten or more years of relevant experience.
Strong knowledge of QMS, especially in ISO 13485:2003, cGMP, FDA, and other relevant 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, maintain hearing and speech abilities.
· Position requires data entry and regular use of a computer/keyboard/mouse for extended periods.
· Concentration and mental attentiveness are necessary for the job.
· Specific vision abilities required include close vision, color vision, and ability to adjust focus.
· Primarily works in an office environment, with occasional presence on the manufacturing floor. Travel is required. Some weekend or evening work may be necessary.