Job Title: Quality Engineer
Maintains quality presence; releases raw materials, in-process materials, and finished product; supports investigations and works with owning departments to resolve deviations and complaints; conducts annual product reviews throughout the Delivery Science organization. Assures the quality of manufactured products is compliant with all applicable regulations and guidelines. Assists with preparing for and hosting of Regulatory and customer audits.
The Quality Engineer interacts with staff throughout Foster Delivery Science and Foster Corporation to ensure that the quality system is functioning properly and provides training, tools and techniques to enable others to achieve quality.
Is responsible for the Quality oversight of the Foster Delivery Science area. This includes Quality functions such as the Environmental Monitoring (EM) program, equipment qualification and maintenance support, nonconformance, corrective and preventive action, documents (i.e. Master Batch Records), and supplier quality.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Implements and maintains quality systems, policies and procedures that ensure compliance to ISO 13485, cGMP, FDA (i.e. 21CFR11, 820, 210, 211) and other applicable standards.
- Performs complex manufacturing batch production record reviews and approval in support of product release in accordance with specifications and procedures.
- Samples, inspects, and releases consumable items and manufacturing components per specifications.
- Monitors various stages of processing along with the appropriate paperwork in compliance with specifications and procedures.
- Drafts and reviews specifications and procedures.
- Reviews Engineering and Operations documents including IQ, OQ, PQ/PV documents for manufacturing equipment and facility utilities
- Reviews and approves nonconformance reports, investigations and CAPAs associated with incoming, in process and production batch processing.
- Provides guidance and direction to less experienced staff.
- Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
- Responsible for Foster Delivery Science quality oversight for quality presence, release of materials, and finished product, investigations and nonconformances, CAPA, complaints, supplier management and supporting Management Review.
- Provide leadership, guidance and problem solving skills to employees within the department and as a member of cross functional teams.
- Assists with preparing for and participating in customer and regulatory agency inspections, e.g. FDA, ISO, EMEA, etc.
- Promotes quality achievement and performance improvement throughout Foster Delivery Science.
- Monitor and advise on the performance of the quality management system
· Supports the development and helps maintains a high quality staff.
· Perform testing for manufacturing and product development support.
- Other duties as assigned by Director of Quality and Regulatory, Foster Delivery Science
- This position has no direct supervisor responsibilities
- This position may provide leadership to teams or groups formed for specific objectives
- Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial medical device / pharmaceutical in an ISO and FDA regulated environment
- Knowledge of plastics manufacturing, analytical testing is highly desirable.
- Extensive knowledge of ISO, US and EU cGMP regulations
- Knowledge of pharmaceutical and finished product manufacturing, analytical testing is desirable
- Knowledge of electronic manufacturing support systems including any of the following: ERP and QMS desirable
- Experience with FDA Preapproval Inspection preparation and management is essential.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Familiarity with the tools, concepts and methodologies of Quality Management Systems.
- Strong analytical, problem solving, and decision making skills (i.e. DMAIC, FMEA, DOE, SPC, Lean)
- Attention to detail is crucial in this position
- Able to work closely with all other departments within Foster Delivery Science
- Able to work closely with all customers and suppliers
- Flexible in handling multiple and changing work assignments on a daily basis
- Self-reliant in meeting goals and objectives
- Ability to effectively present information and respond to questions from groups of managers and customers.
EDUCATION AND/OR EXPERIENCE
- Knowledge of science generally attained through studies resulting in a B.S., or higher, in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
- A minimum of 4 years of experience in medical device / pharmaceutical regulated environment with an at least 3 years focused on Quality Systems
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
- Ability to write detailed procedures and work instructions
- Ability to speak effectively before groups of customers or employees of the organization
- Ability to work with mathematical concepts and fundamentals of applied statistics
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Ability to apply and interpret statistical data.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Makes sound decisions and applies appropriate notification to management as appropriate. Ability to deal with problems involving several concrete variables in standardized situations
CERTIFICATES, LICENSES, REGISTRATIONS
Certificate in Process Improvement and/or Lean – Highly desirable
ISPE, ASQ (American Society for Quality) and/or ISO certification as an Auditor, Engineer, or Manager - desirable
Physical demands of this job are minimal. The employee must occasionally lift and/or move up to 30 pounds. Working with proper PPE and gowning for GMP Cleanrooms and Analytical Laboratories is required.
Work is largely performed in an office environment, laboratory and manufacturing facility where one must be aware of the presence of workplace standards including machinery and testing equipment. Use of protective gowning for the Clean Room areas and personal protective equipment (PPE) will be required in some portions of the facility.