Senior Quality Assurance Engineer

Hologic•Newark, DE

9h•$97,600 - $125,200

About The Position

Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma). Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

Requirements

Technical Bachelor’s Degree
2-5 Years with Technical Bachelor’s Degree
1-3 Years with Master’s Degree
0-1 Years with PhD
Excellent computer skills including ability to use word processing, spreadsheet programs and databases
Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
Excellent technical writing skills with ability to write quality assurance reports and details procedures
Good knowledge of microbiology, molecular biology, biochemistry, chemistry and/or related disciplines
Good understanding of nucleic acid amplification and detection technologies
Good understanding of Scientific Method and statistical analysis
Ability to plan and supervise execution of projects, keep to timelines and prioritize resources
Ability to troubleshoot and solve technical issues across multiple assays and platforms
Ability to analyze data and come to valid scientific conclusions
Ability to document technical work and lead investigations and improvements in a GMP environment
Knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
Good technical writing skills and ability to prepare and present data
Excellent collaboration and interpersonal skills

Nice To Haves

Experience with sterilization and cleanroom processes is beneficial.
Working knowledge of FDA and ISO regulations that govern the Medical Device is beneficial.
Certified Quality Engineer is beneficial.

Responsibilities

Write & Execute and Coach Others on how to perform TMV's
Write & Execute and Coach Others on Simple Change Orders (Simple Procedure updates, no validations required, clarifications, etc)
Lead/Own Moderate to Complex Project Change Orders (validations, risk analysis updates, creation or major changes of SOP's/documents, etc)
Write & Execute and Coach Others on how to perform PQ's
Lead/Own CAPA's and HRA's/HHE's
Model all quality values and coaches’ others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement.
Collaborate and communicate effectively with junior level employees, peers and cross-functional teams across all levels of the organization.
Collaborates with Operations, Engineering and R&D Accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
Accountable for the development, training delivery and monitoring of procedures, investigation procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive requirements
Acts with urgency to identify and lead the timely resolution of quality issues.
Lead moderate to complex risk management, defect investigation, customer complaint investigation and corrective action activities.
Leads quality projects and will provide cost, schedule and resource needs for assigned projects.
Responsible for monitoring and providing regular communication and updates on success factors such as progress, schedule, budget, project risks and resource of needs gaps.
Ensure data, protocols and reports meet project objectives.
Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry.
Collaborate with other engineers and promote learning, development and knowledge transfer.
Mentors and coaches junior Engineering staff.
Provides technical expertise for Non-Conformance Events risk assessments and planned deviations.
Author technical protocols, technical reports, and complaint investigation reports.
Responsible for processes such as QSI, MRB, NCE, CAPA and SCAR process.
Responsible for the review and approval process for ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation.
Responsible compliance required facility and supplier audits and Notified Body and FDA inspections.
Executes analysis of large datasets.
Analyze associated lines of investigation and devise and recommend methods to resolve problems.
May participate in external collaborations.
May present results and progress for management and key external customer review.
Identify and recommend improvements to the organization, processes, procedures and the Quality Management System.