QC Director Jobs

POSITION SUMMARY:

Reporting to the Vice President of Clinical and Regulatory the Director of Quality is responsible for implementing, and maintaining the Histogenics Quality System to insure compliance with national and international regulations and license requirements and to meet the needs of the Company’s quality policy and objectives by actively managing and promoting the mandates for continuous improvement. The Director is responsible for oversight of Quality Assurance and Quality Control functions, which minimally include the testing and disposition of products on behalf of Histogenics.

MAJOR DUTIES AND RESPONSIBILITIES:

Strategy and implementation

• Provide leadership for developing and directing Quality Assurance and quality improvement initiatives for all products and services.
• Lead, develop and recruit a highly effective quality staff of appropriate technical depth to support Quality Assurance and Quality Control functions.
• Responsible for effective quality management such that products are designed, manufactured and shipped to customers where quality safety and effectiveness are assured.

• Guide the organization on general quality compliance issues. Perform internal and external GLP, GMP and GCP audits, including suppliers and other third parties.
• Lead all site Health Authority or compliance inspections.
• Maintain an up to date working knowledge of national and international standards and guidelines.
• Maintain direct control over corrective and preventative action, document control and audit programs.
• Manage documentation related to Quality System, ISO and FDA guidelines. Validate reports and other documents that comprise the registration package(s) for products.
• Develop, implement, communicate and maintain a quality plan to bring the Company’s Quality Systems and Policies into compliance with ISO and FDA quality system requirements.
• Report on a timely basis the performance of the quality system, any non-compliance issues and recommended actions.
• Establish and maintain a monitoring and trending program to ensure general state of compliance is under control and continuously improving.

• Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the quality functions.
• Provide leadership for the development, implementation, communication and maintenance of quality systems policies and procedures in accordance with US FDA QSR regulations and ISO requirements.
• Work with the entire organization to implement new programs and policies, including support for training the organization.

• Utilize internal resources and external consultants/vendors to establish effective quality systems operations.
• Establish efficient and scalable capabilities for archiving relevant documents, including controlled documents.
• Drive company SOP system, including maintenance of existing SOPs and development of new ones.
• Manage and maintain the Company’s internal quality audit program and assess improvement initiatives resulting from all Quality Audits, internal and external.
• Effectively interact with Advance Manufacturing and Product Development teams to maintain product supply and help introduce new products.
• Review and establish all Quality Assurance and Quality Control Systems applicable to cGMP manufacturing
• Manage and develop the teams to support raw material, final product and clinical productions controls applying current quality regulations.
• Oversee the Quality Control analytical and microbiology functions ensuring appropriate laboratory controls, methods development and methods validation are conducted.
• Ensure facility, equipment and process validations are conducted to appropriately support clinical evaluations
• Implement and oversee GMP training and safety programs
• Provide ongoing coaching, developing and mentoring of QA and QC staff

Work Experience:

• Requires a minimum of 10 years increasing responsibility in Quality Assurance and Quality Control management and systems implementation in the medical device industry; biotechnology or pharmaceutical industry
• Experience in ISO, QSR, QC testing and QSIT-type audits.
• Solid understanding and experience in the following areas
  • internal and external audit functions
  • oversight of CAPA programs
  • establishing product stability programs
  • sterilization validations
  • FDA and cGMP regulations for biologics
• Experience with medical devices is a plus
• Experience in ISO, QSR, QC testing and QSIT-type audits.
• Demonstrated leadership ability and experience, including staff recruitment and development

• Strong background in change control systems, documentation systems and design control
• Strong analytical and project management skills with prior experience in study protocol development and report writing
• Strong training and mentoring skills
• Proficiency in Microsoft applications

Who is Collections Etc.?

Collections Etc. is one of the fastest growing and highly successful giftware catalog companies. Our unique selection of value priced merchandise and customer focus has propelled the growth of the company by capturing the hearts and loyalty of our customers.

This position will work out of our corporate headquarters in Elk Grove Village, IL.

What will you be doing for us?

You’ll manage our product testing and inspection program.

We offer hundreds of hardline and softline products in areas such as home décor, housewares, garden accessories and a variety of giftware. (To view our items, visit our website at www.CollectionsEtc.com). This position plans and directs the technical activities of our outsourced product testing and inspection program, including statistical sampling inspection and inspection techniques, testing methods, and product acceptance standards. Responsibilities include:

• Independently plans, coordinates, and directs all outsourced vendor/agent/factory/third party testing and inspection activities.
  
• Acts as the Company’s technical expert in product testing and inspections.
  
• Exercises a high degree of skill, broad experience, initiative, and mastery of QA concepts and principles in constantly adapting the testing and inspection program to ever changing industry, product and testing/inspection standards, criteria and techniques.
  
• Plans and directs implementation of a supplier certification program and vendor “Report Card” to ensure compliance with the Company’s requirements.
  
• Independently designs, organizes, and carries out special studies and projects related to testing/inspection programs’ administration resulting in new test methods, policies or organization changes, and in resolving critical problems.
  
• Ensures compliance with established policies and procedures of the Company’s Quality program.
  
• Maintains close coordination with suppliers’ quality control and management representatives and servers as the communication liaison with vendors, agents, factories on outsourced testing and/or inspection issues.
  
• Uses broad experience, diplomacy, and a high degree of skill to arbitrate disputes and to assist Company buyers during disputes or meetings with supplier representatives on quality testing/inspection techniques, product rejections, or returns of defective merchandise.
  
• Provides recommendations to inventory management and merchandising staff relative to disposition of defective merchandise.

What do you need to bring to the table?

• Associate’s or Bachelor’s Degree in one of the engineering, technical, or related science disciplines or equivalent experience.
  
• Basic understanding of Six Sigma, TQM, AQL, or similar quality programs; Six Sigma class work or training preferred.
  
• Minimum of four years of progressively responsible experience in quality assurance field plus a minimum of three years specialized experience in assuring quality of consumer goods.
  
• Must possess and be able to apply knowledge of quality assurance / quality control, methods, principles, and practices, including statistical analysis and sampling; knowledge of statistical sampling plans and a variety of standard test methods such as ASTM, UL, AATCC, etc.
  
• Knowledge and experience in using proven quality principles, techniques, and methods in the areas of hardline and softline testing and inspection.
  
• Computer literate with MS Office, proficiency in Word, Excel; knowledge in Access helpful.
  
• Effective communication, analytical, organizational, and interpersonal skills in a team-oriented setting.

What do you get from us?

• The opportunity to work for a great company
  
• A track record of growth
  
• Competitive Salary + Bonus potential
  
• Friendly, Comfortable, and Productive work environment!

Plus we offer a generous benefits package which includes:

• Medical Insurance
  
• Dental Insurance
  
• Vision Insurance
  
• 401(k) Savings and Investment Plan
  
• Short- and Long-Term Disability coverage
  
• Life Insurance for Self and Dependents
  
• Flexible Spending Accounts
  
• Tuition Reimbursement
  
• Paid Time Off Plan
  
• Onsite Subsidized Cafeteria
  
• Onsite Fitness Center
  
• Employee Discounts AND MORE!!!

For consideration, please email resume and salary history to: Register to View

Equal Opportunity Employer