Quality Engineer

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries

     

JOB DESCRIPTION:

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Our location in Westford, MA, currently has an opportunity for a Quality Engineer.  

As a Quality Engineer you will do design assurance which will assure new or modified products conform to quality standards and establishes compliance with the quality system. You will be responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

WHAT YOU’LL DO

• Drive on-time completion of Design Control Deliverables

• Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities

• Lead Risk Management activities from product Concept through Commercialization

• Support design test and inspection method development, and lead method validation activities

• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

• Support manufacturing process development & qualification for new product commercialization and product changes

• Support and ensure internal & external audit responses

• Support and ensure on time product re-certifications

• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements

• Support and ensure objective component specification definitions, qualifications, supplied component sampling plan development, and vendor qualifications

• Accountable for development, execution and analysis of biocompatibility and sterilization qualifications

• Complete Document Change Request Reviews in a timely and objective manner

• Perform other duties and responsibilities as assigned by management.

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications in collaboration with all levels of employees, customers, contractors, and vendors.

• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Perform other related duties and responsibilities, on occasion, as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor level degree in Engineering or Technical Field, advanced degree preferred.
• 2+ years technical experience
• Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, and ISO 13485
• Solid communication and interpersonal skills
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Advanced computer skills, including statistical/data analysis and report writing skills
• Prior medical device experience preferred
• ASQ CQT, CQE, CQA certification preferred
• Six Sigma root cause analysis/problem solving training and experience preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.
• Ability to maintain regular and predictable attendance.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

·  A fast-paced work environment where your safety is our priority (Include for Manufacturing roles only)
·  Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only)
·  Training and career development , with onboarding programs for new employees and tuition assistance
·  Financial security through competitive compensation, incentives and retirement plans
·  Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
·  Paid time off
·  401(k) retirement savings with a generous company match
·  The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

AVD Vascular

        

LOCATION:

United States > Massachusetts > Westford : 4 Robbins Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment

     
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf