Massachusetts Jobs

Description:

The Laboratory Quality Engineer is responsible for the completion of quality deliverables within the laboratory including Audit, CAPA, and Nonconformance investigation and management to meet quality performance measures established by the business. This role is responsible for providing quality review and approval of deliverables to support the laboratory including test methods, test method validations, instrument qualifications, software validations, and other artifacts as assigned. This role is responsible for ensuring the level of quality outputs provided by their assigned laboratory(s). This role will partner with Test Engineers, Material Scientists, R&D Engineers, other Quality Engineers, Quality Systems, and other functions to complete activities. SECTION 2: DUTIES & RESPONSIBILITIES* Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: • Responsible for overall quality system execution for assigned laboratory teams with oversight. This includes quality system metrics such as nonconformance timeliness and aging, CAPA timeliness and aging, and Audit observation timeliness and aging. • Responsible for coordinating laboratory accreditation activities (ie ISO/IEC 17025) for assigned laboratory teams, as applicable. • Responsible for coordinating nonconformances, CAPA, and audit observations, including execution corresponding actions, for assigned laboratory teams with oversight. • Responsible for performing gap assessments to internal JNJ or external standards regarding quality system elements. • Review and approve documentation as Quality Engineer including Instrument Lifecycle Management / Instrument Qualification deliverables, test protocols and reports, test methods, fixture drawings, and any other laboratory deliverables requiring quality review and approval. • Partner with Lab Operations personnel to create and implement procedural or systems updates. • Participate in laboratory-based projects, programs, or initiatives as directed. • Establish and manage relationships with all stakeholders (global & domestic). • Liaise with stakeholders as needed support project goals. • Communicate and present activities to stakeholders including lab leadership. • Ability to appropriately communicate and manage confidential information. • Ability to effectively communicate with customers (incl. surgeons, vendors, leadership, and most internal departments).

Skills:

Quality engineering, Root cause analysis, Medical device, Capa, Iso 13485, Audit, Corrective action plans, non conforming, Engineering, Quality management system

Top Skills Details:

Quality engineering,Root cause analysis,Medical device,Capa,Iso 13485,Audit,Corrective action plans,non conforming,Engineering

Additional Skills & Qualifications:

• Engineering, or relevant technical degree: o Bachelor’s Degree with 0 to 2 years of related experience • Quality certification (CQE, etc) preferred. • Medical device or experience in a regulated industry is preferred. • Laboratory experience is preferred. • Experience with technical writing is preferred • Knowledge of current ASTM/ISO test standards is preferred • Knowledge of regulatory guidelines is preferred • Knowledge of ISO 17025 accreditation is preferred

Experience Level:

Entry Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.