Senior Quality Assurance Engineer 4

Hologic • Newark, NJ

8d

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). Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept/peer review). Level at which career may plateau. Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead). Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise. 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. Collaborate and communicate effectively with junior level employees, peers and cross-functional teams across all levels of the organization. Participate as a core team to plan tasks, address resource needs and provides technical quality engineering expertise to the development of products and manufacturing processes to ensure robust product builds and the production of high-quality products and manufacturing practices. Accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations. Owns the development, training delivery and monitoring of procedures, investigation procedures and test methods to assure 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. Accountable for risk management, defect investigation, customer complaint 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. Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry. Collaborates with other engineers and promotes learning, development and knowledge transfer. Mentors and coaches less senior staff. Provides technical expertise for Non-Conformance Events risk assessments and planned deviations. Accountable for the creation of technical protocols, technical reports, and complaint investigation reports. Accountable for processes such as MRB, NCE, CAPA and SCAR process. Accountable for 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. Develops Product Quality Plans Lead plant efforts to maintain quality requirements and certifications. Accountable compliance required facility and supplier audits and Notified Body and FDA inspections. 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. Drives the development of efficient, consistent processes and builds a workplace culture of continuous improvement. Champions opportunities to implement new tools, technologies and methods.

Requirements

• Bachelor’s Degree (Technical Field Preferred), May have Master’s Degree, May have PhD
• 8+ Years with Bachelor’s Degree
• 6+ Years with Master’s Degree
• 3+ Years with PhD
• Advanced knowledge of ERP and PLM Systems, word processing, spreadsheet programs and databases
• Ability to lead and motivate a high performing project team and supervise execution of projects, keep to timelines and prioritize resources
• Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
• Excellent collaboration and interpersonal skills. Adapts communication style to suite different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions.
• Very good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements.
• Ability to develop and deliver high quality presentations
• Comprehensive 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
• Advanced ability to analyze data and come to valid scientific conclusions
• Ability to simultaneously manage multiple large-scale projects in various lifecycle stages

Nice To Haves

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

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.
• Collaborate and communicate effectively with junior level employees, peers and cross-functional teams across all levels of the organization.
• Participate as a core team to plan tasks, address resource needs and provides technical quality engineering expertise to the development of products and manufacturing processes to ensure robust product builds and the production of high-quality products and manufacturing practices.
• Accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
• Owns the development, training delivery and monitoring of procedures, investigation procedures and test methods to assure 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.
• Accountable for risk management, defect investigation, customer complaint 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.
• Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry.
• Collaborates with other engineers and promotes learning, development and knowledge transfer.
• Mentors and coaches less senior staff.
• Provides technical expertise for Non-Conformance Events risk assessments and planned deviations.
• Accountable for the creation of technical protocols, technical reports, and complaint investigation reports.
• Accountable for processes such as MRB, NCE, CAPA and SCAR process.
• Accountable for 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.
• Develops Product Quality Plans
• Lead plant efforts to maintain quality requirements and certifications.
• Accountable compliance required facility and supplier audits and Notified Body and FDA inspections.
• 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.
• Drives the development of efficient, consistent processes and builds a workplace culture of continuous improvement.
• Champions opportunities to implement new tools, technologies and methods.

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 $119,300 - $186,000 and is bonus eligible.
• Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

What This Job Offers

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