Senior Quality Engineer

Summary

Our client, a rapidly growing medical device firm, requires a quality engineer to join their team to perform validations and qualifications of new/existing equipment and processes in a medical device environment. Focus on validations will be to document the processes and equipment to current regulatory standards and requirements.

Duties / Expectations of Role

Will provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing and laboratory process controls.

Communicates current and applicable good manufacturing practices (GMP) and good laboratory practices (GLP) (e.g.: ISO13485 / 21 CFR Part 820 / CMDR) to business partners.

Executes functions needed to support change control activities and document management requirements.

Collaborates with business partners and peers to define validation and change control activity requirements for individual projects.

Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on.

Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability / reliability.

Leads / participates in the preparation of risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA).

Writes/revises or reviews /approves a variety of validation lifecycle documents.

Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports.

Supports the delivery of system solutions by assuring validation activities are conducted in a compliant but cost effective manner.

Works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations.

Performs investigations and troubleshoots validation problems for equipment, performance process and system and so on.

Audits the compliance of validation activities and assists during internal / external audits. Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.

Proactively identifies and resolves issues, and escalates concerns as appropriate.

Ensures corrective actions are completed in a timely manner.

Promotes continuous improvement by ensuring adherence to quality principles.

Seeks out and actively participates in business initiatives that contribute to service excellence. Collaborates and teams with Laboratory, Quality and Validation Engineering, LIMS, and project management personnel.

Mandatory Requirements

Bachelor of Science in Engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE).

5+ years of experience in Quality within a medical device organization.

A strong background in validation (and statistical tools such as Sampling Plans, Experimental Design and Optimization) is required.

Knowledge of current and applicable GMP regulations is required.

Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required.

Experience in Supplier Quality

Term & Start

6 month initial contract with possible 6 mo extension.

Start ASAP

Partial onsite weekly in southern Florida