Manufacturing Quality Engineer

About the role

The Manufacturing Quality Engineer designs, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. They are 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. This role also involves designing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products.

Responsibilities

• Write & Execute TMV's and Simple Change Orders (Simple Procedure updates, no validations required, clarifications, etc)
• Support Moderate to Complex Project Change Orders (validations, risk analysis updates, creation or major changes of SOP's/documents, etc)
• Write & Execute PQ's; Lead/Own CAPA's; Support HRA's/HHE's
• Model all quality values and coach 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.
• Provide quality engineering support to Operations, Engineering and R&D in the design and manufacture of medical devices to ensure robust product builds and the production of high-quality products and manufacturing practices.
• Responsible for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
• Develops and implements procedures, inspection procedures, and test methods in compliance with QMS, Medical Device Quality System Regulation, and Medical Device Directive requirements. Provides training as required.
• Acts with urgency to Identify and provide timely resolution to quality issues. Perform risk assessments and update risk management documentation as required.
• Performs customer complaint investigations, root cause investigations, root cause analysis, problem solving, and corrective actions.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in the industry.
• Investigates and processes Quality System Investigations (QSI) and Non-Conforming Events (NCE).
• Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system.
• Active participation in processes and meetings such as MRB, NCE, CAPA, and SCAR process.
• Review and approve routine to moderately complex ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation.
• Active participant in facility and supplier audits and Notified Body and FDA inspections.

Qualifications

• Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree
• Experience in an FDA regulated industry is beneficial.
• 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 presentation skills.
• Knowledge of GMP and GDP Principles.
• Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485, and MDD requirements is beneficial.
• Knowledge of microbiology, molecular biology, biochemistry, chemistry, and/or related disciplines is beneficial.
• Understanding of nucleic acid amplification and detection technologies is beneficial.
• Understanding of Scientific Method and statistical analysis is beneficial.
• Knowledge of Oracle and Agile is beneficial.
• Certified Quality Engineer is beneficial.

Benefits

Hologic offers a competitive annualized base salary range of $78,000 - $100,000, with potential for bonuses. Final compensation packages will depend on relevant experience, skillset, knowledge, education, business needs, and market demand.

Pay

Annualized base salary range: $78,000 - $100,000

Schedule

N/A