AQ ENGINEER II

TE Connectivity Corporation; Plymouth (MN); On-site; USD 83,000 - 124,000; Full time

Benefits offered by this job

Health insurance

401(k)

Disability insurance

Life insurance

Employee stock purchase plan

Paid time off

Voluntary benefits

Job summary

TE Connectivity is seeking a Quality Engineer in the United States to support QSR/QMS compliance and drive continuous improvement in medical device manufacturing. You will implement质量 control systems, perform CAPA investigations, and collaborate with cross-functional teams to ensure regulatory compliance and product reliability.

Candidate should have a BS/BA in engineering or science, relevant MS or certifications, and at least 3 years in a regulated medical device environment.

Qualifications

• BS/BA degree with scientific/engineering emphasis required.
• AQS Certified Quality Engineer or MS in medical devices or related field is preferred.
• Six Sigma Green/Black belt recommended.
• Minimum 3 years’ experience in a regulated medical device environment.

Responsibilities

• Develop and implement quality control systems and processes.
• Perform CAPA investigations and drive root cause analysis.
• Support regulatory audits and ensure compliance with QSR/ISO 13485.
• Write protocols and technical investigations ensuring regulatory compliance.

Skills

CAPA management

Root cause analysis

Gage R&R

Statistical methods

Education

BS/BA degree in engineering or science

MS in Medical devices engineering or Engineering Management or Mechanical

Six Sigma Green/Black belt

Job description

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Description:

Job Overview

TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systemsto comply with customer and contractual requirements through established reliability factors. They design,recommend revisions and install quality control systems, develop and document analytical methods forestablishing reliability of products and their components and conduct analysis on relative reliability with regards tocost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary.

They are responsible for policies and practices to comply with applicable governmentregulations and industry requirements related to product environmental compliance, the implementation andmanagement of technical and testing standards and specifications, quality control and reliability programsgoverning materials, product and processes, resulting in the optimization of material and labor, as well as failureanalysis, root cause, corrective action and customer communication.

This position is responsible for direct interaction and support and customer quality management, assuring thatQSRs and QMS are in accordance with regulatory standards and promote continuous improvement of the QualitySystem. Other duties may be assigned on an individual basis: This position will report to the Director/Quality Assurance. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the QualityManagement System (QMS).

Job Requirements

• Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).
• Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
• Develop and maintain the pFMEA process for manufacturing.
• Support/participate in regulatory agency and customer quality audits.
• Participate in design control activities to ensure that product meet specifications, reliability, andmanufacturability.
• Participate in initiating non conformance report, Containment, root cause investigation, dispositions and implementation of CAPA .
• Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues.
• Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
• Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
• Provide quality engineering support to sending sites during project transfers.
• Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.

What your background should look like

• BS/BA degree with a scientific/engineering emphasis required.
• AQS Certified Quality Engineer or MS in Medical devices engineering, Engineering Management or Mechanical
• Six Sigma Green/Black belt recommended
• Minimum of 3 years’ experience with MS in a related regulated medical device environment. Catheter/MI experiences an advantage.

Competencies

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork

ABOUT TE CONNECTIVITY

TE Connectivity plc (NYSE: TEL) is a global industrial technology leader creating a safer, sustainable, productive, and connected future. As a trusted innovation partner, our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, energy networks, automated factories, data centers enabling artificial intelligence, and more.

• Competitive base salary commensurate with experience: $82,600 - 124,000 annually(subject to change dependent on physical location)
• Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
• Total Compensation = Base Salary + Incentive(s) + Benefits

BENEFITS

• A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

EOE, Including Disability/Vets