Quality Engineer Tech - II

Adecco Staffing is assisting a well-known Medical Device Manufacturing facility in Chelmsford MA with their needs for a Quality Engineer Tech. II.

Pay : $44 - $46 / Hr

Shift / Hours : Monday - Friday 8am - 5pm

POSITION SUMMARY :

The Quality Engineer II will be responsible for cross-functional quality assurance, quality management / compliance, quality control, and activities associated with all products and processes with a focus on manufacturing activities. In support of Corporate Quality Objectives, the incumbent will contribute, manage, and drive improvement in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual Audit readiness; Product Complaints identified as manufacturing related; and Quality Improvement efforts related to Global or Local initiatives, such as Cost Improvement Projects. Additionally, the Quality Engineer II will support the Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality and services are achieved and maintained.

PRINCIPAL RESPONSIBILITIES :

Nonconformance (NC) and CAPA processing - lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data.

Support Incoming & In-Process Inspection teams.

Support the value stream with investigations required for field corrective actions including risk evaluation.

Participate in internal audit activities and support supplier corrective actions as needed. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits.

Production & Process Controls - review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and process run sheets.

Documentation Control - perform change controls (ADC / ECR / ECOs) as needed.

Training - Perform QA training certifications on new production operators as needed.

Support Engineering with new product development with quality planning, risk evaluation, and validation.

Perform any additional QA tasks, as assigned by QA Manager.

Maintain compliance with Teleflex Global & local procedures and policies.

EDUCATION / EXPERIENCE REQUIREMENTS :

Minimum 4-year degree in an engineering discipline - Mechanical, Biomedical, Plastics, Industrial, etc.

Minimum 2-3 years' experience of quality and / or related manufacturing / engineering role, preferably in a manufacturing site.

Quality system management and deployment experience preferred.

Problem-solving and quality improvement, including quantitative methods.

Validations (product and process IQ / OQ / PQ).

SPECIALIZED SKILLS & OTHER REQUIREMENTS :

Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements.

Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.

Working knowledge and / or experience with SAP and AGILE is strongly preferred.

Good listening, verbal, and written communication skills

Excellent interpersonal skills with a demonstrated ability to work in a team environment.

Ability to prioritize and adapt to shifting priorities.

If you are interested, please apply directly to this job posting!

Pay Details : $44.00 to $46.00 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

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable :

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only : It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.