Quality Engineer - Life Sciences Bioprocessing

Job description

3372956
Additional Cities

Westborough, Boston, Hartford, Nashua, Providence
Career Level

Entry-Level
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare BioPharma
Function

Quality
Country/Territory

United States
Additional States/Provinces

Connecticut, Massachusetts, New Hampshire, Rhode Island
Postal Code

01581-1019
Role Summary/Purpose

This position is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design transfer, manufacturing, and distribution.
Essential Responsibilities

·  Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.

·  Responsible for the review and approval of Engineering Change Orders (ECOs).

·  Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency.

·  Coordinator of deviations and concessions for manufacturing.

·  Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.

·  Initiates and owns nonconformance reports and CAPAs for manufacturing related issues.

·  Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.

·  Perform and document investigations into manufacturing related process and product defects.

·  Responsible for coordinating field actions related to manufacturing caused issues.

·  Performs a variety of tasks in support of product and process design as assigned by the departmental manager.

*** Candidates should note that this role will be in scope for the proposed transition of GE Biopharma to Danaher and will transfer to Danaher at close of this transaction.
Qualifications/Requirements

·  Bachelor Degree or a minimum of 4 years work experience.

·  Minimum of 1 year experience working in a regulated industry or a Masters degree

·  Ability to communicate effectively in English (both written and oral).

·  Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Desired Characteristics

·  Minimum of 3 years experience in a regulated industry is preferred

·  Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

·  Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

·  Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

·  Demonstrated collaboration, negotiation & conflict resolution skills

·  Excellent communication skills (written and oral)

·  Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

·  Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.

·  Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)

·  Experience leading and implementing change

·  Experience performing internal audits and participating in external audits

·  Exceptional analytical, problem solving & root-cause analysis skills

·  Ability to multi-task & handle tasks with competing priorities effectively

·  Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
About Us

GE Healthcare Life Sciences www.corporate.gehealthcare.com There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Primary Country

United States
Primary State/Province

Massachusetts
Primary City

Westborough