Quality Engineer

Kelly Services is currently seeking a Quality Engineer for one of our top clients in Raynham, MA.

• 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 customer, 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 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 .

SECTION 3: EXPERIENCE AND EDUCATION

• Engineering, or relevant technical degree:
• 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

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Good Documentation Practice
• Verbal and written communication skills
• Technical writing skills
• Problem analyzing and solving
• Project management
• Ability to effectively work on multiple tasks

Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

Why Kelly®?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

As a Kelly Services employee, you will have access to numerous perks, including:

• Vacation and sick pay
• Paid holidays
• 401(k) plan
• Group medical, vision, dental, life, and short-term disability insurance options
• Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
• Kelly Learning Center offers free courses and trainings
• Weekly pay

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.