Designs, evaluates and implements Quality Assurance programs and systems for Manufacturing and Quality Control to ensure compliance with regulatory requirements. Responsible for leading the investigation and resolution of assigned quality issues. Works with, Quality and Manufacturing to create and/or modify methods and procedures to ensure that appropriate tests are conducted and that products, materials, and manufacturing equipment meet required standards. Develops, applies, revises, maintains and leads these activities for quality standards for product, equipment, methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. Analyzes reports and returned products and recommends corrective action. Prepares documentation for inspection/testing procedures. Lead and/or participate in internal and supplier audits to ensure compliance with ISO and QSR procedures.
Primary Duties and Responsibilities:
Monitors quality data from Incoming Inspection, NCMR’s, Deviations, in process, and Final Package operations. Identifies quality problem trends and works to implement resolution plans independently or by working with, Process Engineering, Equipment Engineering, Manufacturing, and Failure Analysis.
Identifies, investigates, troubleshoots and resolves identified quality issues (including customer complaints) independently or by working with Process Engineering, Equipment Engineering, Manufacturing, and Failure Analysis.
Performs statistical analysis to analyze trends, and works with manufacturing to troubleshoot complaints and recommends corrective action for processes as well as equipment calibration.
Assure compliance to in-house and/or external specifications and standards such as QSR (Quality System Regulations) and ISO regulations (13485 and ISO 14971, Application of Risk Management to Medical Devices).
May develop tests to conduct supplier evaluation audits and determine qualifications.
Reviews and approves validation protocols for product/equipment design changes.
Develops and initiates efficient methods for accurately reporting to management the current status of product quality with respect to quality objectives and goals. Keeps management regularly informed on the status and progress of quality programs and plans.
Knowledgeable regarding and/or exposure to risk management (including ISO 14971) as it relates to products and processes. Responsible for providing input regarding product and process technical risk assessments.
Maintains awareness of quality techniques through continuous review of literature and quality seminars.
Provides guidance and training as required.
Maintains awareness of FDA and other agency regulations, and industry practices.
Works with the QA Management to devise and implement quality strategies and policies.
Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health & Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
Performs internal audits to ensure compliance to applicable ISO and QSR standards and procedures.
Leads other QA Engineers in the activities outlined above.
Performs other related duties and assignments as required.
Bachelor or equivalent
Bachelor or above
Yrs of related experience:
5 years or more
Competencies: (skills, knowledge, abilities)
Strong team work and communication- must be able to interact effectively with all other site functions
Excellent planning and scheduling skills
Knowledge of QSR, ISO 13485, and IVDD
Demonstrated knowledge of scientific principles. Requires thorough knowledge of QSR regulations, and applicable international regulatory requirements.
Must be able to interact effectively with all other site functions.
QSR and ISO 13485:2003 training
ISO 14971 Training
ASQ CQE, CQM/OE or equivalent
ASQ CQE, CQM/OE, CQA, and/or CBA
Typical office environment
State or Province