Director of Quality, Regulatory & Innovation
Medical Indicators, Inc., Trenton, NJ, United States
Director of Quality, Regulatory & Innovation
Full Time Management Hamilton, Trenton, NJ, US
1 Attachments
Salary Range: $130,000.00 To $150,000.00 Annually
SUMMARY Manage standard regulatory duties and executes projects related to organization products/projects with all QA activities and functions.
RESPONSIBILITIES AND DUTIES
Develops and maintains the quality management systems documentation for cGMP and international medical device requirements and certifications.
Lead internal and external audits; assess the business to assure compliance of all Medical Device regulations and standards. Advise management of all significant audit findings, adverse events or post market product issues.
Lead the company’s written response process to address any audit findings.
Demonstrates sound decision making relating to quality management system issues.
Initiate, review and approve regulatory and QMS documentation changes through.
Provides QA support and performs QA Operations activities for non-sterile and sterile manufacturing (batch record review, production records, complaints, inquiries, CAPA, change control, engineering control, etc.).
Takes initiative in follow-ups concerned with quality documentation (e.g., investigations, deviations, non-confirming product, environmental Monitoring, Dose Audit, and other required documentation.)
Alerts management of production trends which may serve as forewarning of process equipment problems and reports findings during quality management meetings and or reviews.
Develops validation documents for the company’s products and processes.
Provides product information to customers with respect to domestic and foreign regulatory requirements in the area of global regulations and related laws. Facilitates both national and international product registration and regulatory submissions.
Responsible for the overall day-to-day operations in the chemistry formulation lab.
Manage continuous improvement project for QA, Engineering and Operations team.
Responsible for controlling and coordinating R&D activities for new products and existing products innovation. Ensure design control processes are being followed as per applicable regulations.
Own and execute the New Product Development (NPD) roadmap (1–2 product launches annually), leading cross-functional teams from concept through commercialization.
Oversee compliant design control activities, including risk management, verification/validation, clinical evaluations or clinical studies where applicable, and design transfer to manufacturing.
Lead formulation and product innovation initiatives to improve performance, cost, manufacturability, and competitive differentiation.
Drive product lifecycle management, incorporating regulatory strategy, post-market data, and customer feedback into continuous improvement efforts.
SUPERVISORY RESPONSIBILITIES
Directly supervises employees within the department(s).
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
COMPETENCIES
Analytical – Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs workflows and procedures.
Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
Project Management – Develops project plans; coordinates projects; communicates changes and progress; completes projects on time and budget; manages project team activities.
Quality – Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
Innovation – Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas; presents ideas and information in a manner that gets others’ attention.
QUALIFICATIONS
BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
5 years of quality assurance / medical device with sterile product experience.
Working knowledge of medical device quality management systems, regulations, directives and standards.
Strong analytical skills including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
Ability to support regulatory and compliance duties of Class 1 Non-Sterile/Sterile Medical Devices.
Proven track record of supporting quality assurance functions for a small, growing company.
PHYSICAL DEMANDS AND WORK ENVIRONMENT The physical demands and environmental characteristics 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 these essential functions.
While performing the duties of this job, the employee is regularly required to sit or stand; use hands and fingers to handle or feel; reach with hands and arms; and talk or hear.
The employee must frequently lift and/or move up to 35 pounds.
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1 Attachments
Salary Range: $130,000.00 To $150,000.00 Annually
SUMMARY Manage standard regulatory duties and executes projects related to organization products/projects with all QA activities and functions.
RESPONSIBILITIES AND DUTIES
Develops and maintains the quality management systems documentation for cGMP and international medical device requirements and certifications.
Lead internal and external audits; assess the business to assure compliance of all Medical Device regulations and standards. Advise management of all significant audit findings, adverse events or post market product issues.
Lead the company’s written response process to address any audit findings.
Demonstrates sound decision making relating to quality management system issues.
Initiate, review and approve regulatory and QMS documentation changes through.
Provides QA support and performs QA Operations activities for non-sterile and sterile manufacturing (batch record review, production records, complaints, inquiries, CAPA, change control, engineering control, etc.).
Takes initiative in follow-ups concerned with quality documentation (e.g., investigations, deviations, non-confirming product, environmental Monitoring, Dose Audit, and other required documentation.)
Alerts management of production trends which may serve as forewarning of process equipment problems and reports findings during quality management meetings and or reviews.
Develops validation documents for the company’s products and processes.
Provides product information to customers with respect to domestic and foreign regulatory requirements in the area of global regulations and related laws. Facilitates both national and international product registration and regulatory submissions.
Responsible for the overall day-to-day operations in the chemistry formulation lab.
Manage continuous improvement project for QA, Engineering and Operations team.
Responsible for controlling and coordinating R&D activities for new products and existing products innovation. Ensure design control processes are being followed as per applicable regulations.
Own and execute the New Product Development (NPD) roadmap (1–2 product launches annually), leading cross-functional teams from concept through commercialization.
Oversee compliant design control activities, including risk management, verification/validation, clinical evaluations or clinical studies where applicable, and design transfer to manufacturing.
Lead formulation and product innovation initiatives to improve performance, cost, manufacturability, and competitive differentiation.
Drive product lifecycle management, incorporating regulatory strategy, post-market data, and customer feedback into continuous improvement efforts.
SUPERVISORY RESPONSIBILITIES
Directly supervises employees within the department(s).
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
COMPETENCIES
Analytical – Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs workflows and procedures.
Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
Project Management – Develops project plans; coordinates projects; communicates changes and progress; completes projects on time and budget; manages project team activities.
Quality – Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
Innovation – Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas; presents ideas and information in a manner that gets others’ attention.
QUALIFICATIONS
BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
5 years of quality assurance / medical device with sterile product experience.
Working knowledge of medical device quality management systems, regulations, directives and standards.
Strong analytical skills including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
Ability to support regulatory and compliance duties of Class 1 Non-Sterile/Sterile Medical Devices.
Proven track record of supporting quality assurance functions for a small, growing company.
PHYSICAL DEMANDS AND WORK ENVIRONMENT The physical demands and environmental characteristics 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 these essential functions.
While performing the duties of this job, the employee is regularly required to sit or stand; use hands and fingers to handle or feel; reach with hands and arms; and talk or hear.
The employee must frequently lift and/or move up to 35 pounds.
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