Ruderfer & Associates
Biopharmaceutical Search Consultants

#2079

Manager, Innovation/Product Development Marketing

 Position:                 Manager, Innovation/Product Development Marketing         Job # 2079

Location                    Chicago Metro, IL

Compensation         Based upon Experience

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 BASIC PURPOSE OF POSITION:

This position reports to the Vice President of Operations, and develops and coordinates the execution of quality systems in accordance with the company’s Quality Policy, Management System, Code of Federal Regulations, and ISO 13485.

 

ESSENTIAL FUNCTIONS & DUTIES:

  • Ensures the company’s Quality Management System is effective, efficient and compliant to applicable ISO standards, FDA regulations and customer requirements for developing and manufacturing medical devices.

  • Analyzes, evaluates, and presents data concerning quality assurance and regulatory affairs related to current and future products to members of the management team.

  • 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).

  • Coordinates non-conforming material and customer complaint investigations and ensures corrective action (CAPA) activities are implemented and verified.

  • Reviews, evaluates and writes quality processes, procedures and policies, and ensures all operations are performed in accordance to SOP, FDA and GMP guidelines.

  • Directs (as Quality Management Representative) internal, vendor, customer, and regulatory audits.

  • Coordinates plant training system to include on-boarding of new employees, GMP training, ISO training, and OJT training as required. 

  • Reviews, evaluates and writes quality processes, procedures and policies, and ensures all operations are performed in accordance to SOP, FDA and GMP guidelines.

  • Reviews technical issues and processes for various departments and provides recommended solutions when applicable.

  • Coordinates product stability activities.

  • Maintains and controls product sterilization processes, including pre/post sterilization and sterility testing activities, audits, and validations.

  • Ensures quality/lab teams are completing tasks and activities in a timely manner and in accordance with applicable work instructions and quality procedures.

  • Coordination of in-process and final quality control activities.

  • Will perform quality testing according to company documented test procedures, GLP, and USP (Good Laboratory Practices and United States Pharmacopeia) in a timely manner.

  • Including testing for bioburden, endotoxin, total organic carbons, etc.

  • Understand good safety practices in handling hazardous chemicals in the laboratories.

  • Maintain in detail all records and keep documents well organized.

  • Will conduct product and process investigations for out-of-specification results.

  • Implement new testing or process improvements.

  • Interface with internal and external labs to ensure product is tested by the required deadlines.

     

EDUCATION AND EXPERIENCE REQUIREMENTS:

  • Bachelor’s Degree.

  • ISO 13485 & 21 CFR Part 820.

  • Sterilization (Gamma and EtO) and packaging standards, requirements and processes.

  • 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.

  • Prefer minimum 5 years QA/QC experience in FDA/GMP/OSHA environment within medical device manufacturing industry.

  • Prefer at least 3 years of supervisory experience.

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