Apothecary Products, Inc.
Job Title: Quality Engineer
Overtime Status: Exempt
Reports To: Quality Manager
Date Last Reviewed: December 11, 2011
The Quality/Regulatory Engineer performs quality responsibilities that include: performing Product Validations, developing Inspection Criteria, supervising inspection technicians, managing external manufacturing inspection programs, supporting Inspection Systems, processing Nonconforming products, assisting Regulatory Affairs in compliance issues, coordinating Document Control, performing Customer Concern Investigations, leading Continual Improvement Initiatives, Calibration, and other related duties as assigned. Additional responsibilities will be added as required.
Quality/Regulatory Technician duties:
Duties Description Estimated Time
Product Validations Validates new/changed products in accordance with specifications and applicable inspection criteria (Pre-Production & Advanced Cases) 15%
Customer Concern Investigations Investigates product issues reported by the customer, logs findings, performs trend analysis, and identifies/implements solutions 15%
External Manufacturing Oversight Samples inspection records from various products from different external manufacturing sites and 3rd party inspection agencies (Midland, HLS Other) 15%
Inspection Criteria, Inspection Systems, & Support Determines inspection criteria, creates function test methods, establishes the inspection criteria and sampling plans, maintains the inspection database, and performs inspections to ensure quality products 15%
Nonconforming products Writes up product nonconformities, works with other departments to identify root cause and to develop corrective plans, assists with their disposition, and maintains the NCM process/database 15%
Supervise Inspection Technicians Handle day to day issues with inspectors, train new inspectors 10%
Regulatory Support Supports the Regulatory Affairs Specialist with ensuring compliance to government and product related regulations including file maintenance 10%
Continual Improvement Initiatives Identifies and implements improvements of processes and/or products 4%
Calibration Maintains logs and gauges to ensure that they are calibrated. 1%
Knowledge, skills and abilities
The Quality/Regulatory Technician should possess excellent communication skills both verbal and written, the ability to interact with employees within all areas of API, a strong understanding of quality related principles and techniques, general understanding of statutory and regulatory requirements as they apply to regulated products, an analytical ability and some experience with ISO. A college degree is preferred.
The Quality Engineer supervises the inspection technicians
Preferred training would include some experience or training in Quality principles including Inspection and Testing Techniques, Problem Solving and Root Cause Analysis, Corrective and Preventive Action, Continual Improvement methodologies, Document Control, prior manufacturing and/or distribution experience. Additional training in Statistics, ISO, ASQ Certification as a Quality Technician or Quality Improvement Associate, Industrial Technology, Lean Manufacturing Techniques and/or Six Sigma Green Belt Training would be a plus.
The Quality Engineer should have understanding in the FDA Regulations applicable to Medical Devices and have an understanding of the regulatory agencies throughout the globe.
The Quality Engineer is expected to operate computers and software programs, be effective in verbal and written communication techniques, and is expected to interact with other departments in a team setting.
Occasional travel maybe expected, less than 2%.
Physical demands for the position include: Sitting 50-60% of the time, Standing 15-20%, Walking 10-15%, and Lifting 5%.