Sr. Quality Engineer Job Chelmsford area,Massachusetts USA,Quality Assurance

Expected Travel:
Up to 10% Requisition About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation — a relentless pursuit of identifying unmet clinical needs — to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.

Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit

Global Operations

Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position

Summary

The Senior Quality Engineer’s primary responsibilities are leading, managing and driving improvement in 4 main areas of the Quality Management System, in support of Corporate Quality Objectives:

CAPA & Nonconformance (NC) Processes;
Perpetual Audit readiness;
Product Complaints identified as manufacturing related;
Quality Improvement efforts related to Global or Local initiatives, such as Pro Active Quality.

The Senior QE position will lead a group of Quality Engineers and work within that team to ensure Quality System requirements are met. Additionally, this position will also support the Operational, Engineering and Post Market Surveillance team activities to ensure that product quality and services are achieved, maintained, and improved.

Principal Responsibilities

Manage Nonconformance process including:

Facilitate daily Material Review Board meetings

Coach and drive NC investigation, containment and corrections while tracking progress; performing follow-up; and ensuring timely and effective completion.

Identify & create trend analysis for Nonconformance quality indicators to initiate CAPA and improvement efforts.

Lead and manage the CAPA process and system by:

Leading monthly CAPA QSRB meetings;

Supporting and coaching CAPA leaders through the CAPA process

Reviewing and/or participating in root cause analysis, corrective action identification and verification of effectiveness planning.

Lead Perpetual Audit readiness activities and conduct internal or process quality audits as needed

Support product complaint investigations and participate in post market surveillance activities.

Lead assigned Quality Improvement project or Quality Objective related initiative

Support product and/or process qualification utilizing validation process. design and process FMEA’s.

Participate in design and phase reviews

Incorporate Design of Experiments (DOE) and other statistical tools within the validation process.

Assist with Supplier Quality management process, including supplier evaluations, SCARs and evaluation of supplier change notification requests. Conduct supplier audits, as necessary.

Support risk management policies and procedures.

Interface with various internal and external resources such as Manufacturing Product Development, Marketing, and Regulatory Affairs to assist with Post Market Surveillance, Product Complaint or Regulatory submissions.

Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

Bachelor’s Degree
ASQ Certified Quality Engineer or Certified Quality Auditor preferred.
7+ years of Quality and/or related Manufacturing/Engineering experience with the following skills:
CAPA, Nonconformance and MRB lead or management role
Planning, controlling and assuring product and process quality
QSR/ISO/CFR regulation knowledge and experience
Medical…


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