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Adecco Healthcare & Life Sciences is seeking a contract Quality Engineer for our Medical Instrumentation partner in Cambridge, MA.

The anticipated wage for this position is between $32 and $34. Hourly wage may depend upon experience, education, geographic location, and other factors.

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria

As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineering subject matter expert. You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions to reach effective problem resolutions. You will also provide quality leadership to improve Critical to Quality (CTQ) parameters to support overall site improvement efforts.

Essential Functions:

• Investigate process/product deviations and out of specification conditions of our local factory and suppliers by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whysetc.

• Ensure DEA compliance and act as a CSP coordinator

• Handle customer complaints with professionalism and efficacy.

• Troubeshoot electrodes and buffer solutions.

• Implement corrective and preventative actions (CAPAs) to prevent recurrence of deviations and nonconformances. Verify effectiveness of implemented changes utilizing the proper quality tools.

• Provide guidance for the disposition of non-conforming material (final product and raw material).

• Perform statistical analysis to monitor process and product performance and react to negative trends.

• Lead change controls for complex improvement projects utilizing risk-based methodologies.

• Have an expert level knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma and control plans.

• Lead and participate in generating risk assessments (product and process- FMEAs).

• Have strong knowledge of process, product and equipment validation principles (i.e IQ/OQ/PQ..etc). This includes generating protocols and reports, creating acceptance criteria, establishing proper sampling plans and completing statistical analysis.

• Maintain the sites Quality Systems conformance to ISO standards and regulatory requirements and policies.

• Drives for continuous improvements in all areas and support improvements efforts, implement changes, and verifies effectiveness of changes.

• Support internal and external audits, customer audits, supplier audits.

• Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.

• Write or revise standard quality control operating procedure and quality system documentation as required.

• Write technical reports such investigation summary reports and change management records.

Requirements - Knowledge - Skills:

• Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline. Graduate degree (MS) also a plus.

• A minimum of 6 years prior experience in a Quality Engineering role preferably in a cGMP Biotech or Life Science site.

• Proven experience with titrators and PH testing

• Strong verbal and written communications skills in English.

• Ability in technical and statistical writing.

• Must have experience in processes and procedures of ISO-9001: 2015 (ISO 13485 preferred) and DEA

• Ability to work in a matrix organization.

• A fundamental understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.

• Understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.

• Strong analytical, problem resolution, judgment and decision-making skills

• Operation requires the use of safety equipment to include but not limited to safety glasses and safety gloves.

• Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions.

• Prior experience with the release and disposition of nonconforming product through the application of risk assessment and root cause analysis tools.

• Demonstrated validation proficiency, with knowledge of product, process and equipment qualifications and validations (IQ/OQ/PQ).

• Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.

• Lean Sigma Green or Black Belt certified a plus.

• ASQ CQE a plus.

• Excellent organization skills with strong attention to details.

• Ability to multitask efficiently to support production demand.

• Computer skills: knowledge of Microsoft Office applications (Word, Excel and PowerPoint) is a must.

Pay Details: $32.00 to $34.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adeccousa.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.