Quality Assurance Engineer 1

Hologic • Newark, NJ

1d • $65,300 - $102,200

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 limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally. Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. Normally receives detailed instructions on all work. Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 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. Provide quality engineering support to Operations, Engineering and R&D in the design and manufacture of medical devices to ensure robust product builds and manufacturing practices. Ensure 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. Participates in Risk Management activities such as assessments and updating Risk Management documentation as required Participates in 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 Non-Conforming Events. (NCE). Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system. Facilitate processes such as NCE, CAPA, SCAR and meetings such as MRB. Review and approve routine ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation. Performing routing and non-routing audits of facility and suppliers for compliance to requirements. Assists in Notified Body and FDA inspections.

Requirements

• Bachelor’s Degree (Technical Field Preferred)
• 0-1 Years
• Strong 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
• Good interpersonal skills to interact with all levels of the company, sometimes in an adversary role

Nice To Haves

• Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements
• Knowledge of microbiology, molecular biology, biochemistry, chemistry and/or related disciplines
• Understanding of nucleic acid amplification and detection technologies
• Understanding of Scientific Method and statistical analysis
• Knowledge of GMP and GDP principles
• Knowledge of Oracle and Agile
• Experience in an FDA regulated industry
• Certified Quality Engineer

Responsibilities

• 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.
• Provide quality engineering support to Operations, Engineering and R&D in the design and manufacture of medical devices to ensure robust product builds and manufacturing practices.
• Ensure 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.
• Participates in Risk Management activities such as assessments and updating Risk Management documentation as required
• Participates in 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 Non-Conforming Events. (NCE).
• Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system.
• Facilitate processes such as NCE, CAPA, SCAR and meetings such as MRB.
• Review and approve routine ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation.
• Performing routing and non-routing audits of facility and suppliers for compliance to requirements.
• Assists in Notified Body and FDA inspections.

Benefits

• We are committed to making Hologic the destination for top talent.
• For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
• The annualized base salary range for this role is $65,300 - $102,200 and is bonus eligible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level