Quality System Engineer

Posted Yesterday
Be an Early Applicant
Batu Kawan, Selatan, Pulau Pinang
Junior
Healthtech
The Role
The Quality System Engineer will perform inspections, analyze product failures, support ISO 14001 systems, and collaborate with various departments to resolve quality-related issues.
Summary Generated by Built In

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Essential Duties

  • Coordinate the return of product samples; perform visual inspection and preliminary investigations related to product issues; forward samples and preliminary investigation reports to responsible departments; review the responses; and notify the customer of the result.
  • Partner with Field Service, Marketing, Manufacturing, Quality and Sales personnel to help resolve customer issues.
  • Partner with manufacturing facilities to analyze failure, CAPA to respond to customer complaints (PIR).
  • Actively provide individual contributions in problem solving efforts to improve quality.
  • The incumbent may be asked to perform other function-related activities in addition to the above mentioned responsibilities as reasonably required by business needs.
  • Comply with the ISO14001 Environmental Management System policy, SOP and requirements
  • Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.
  • Perform other tasks as required.

Supervisory Responsibilities: None

Qualifications

Education

Bachelor's Degree in Engineering - Required

Experience

1+ years: post qualification experience in quality with a focus on manufacturing and distribution - Required

1-3 years: Experience in regulated industries (automotive, aerospace, Medical Devices) - Preferred

Skills

  • Demonstrated analytical skills
  • Effective interpersonal skills
  • Demonstrated written communication skills
  • Strong verbal communication and listening skills
  • Demonstrated problem-solving skills
  • Assumes personal responsibility for actions
  • Good Team Player
  • Proficient in English written and verbal communication skills

Training/Certifications

  • Knowledge of ISO in a regulated industry (Medical Devices, Aerospace, Automotive, etc.) preferred: ISO 13485 & 21 CFR 820, MDD & MDR regulations/guidelines - Preferred
  • Class II or Class III medical devices requirements - Preferred

EEO Policy Statement

Top Skills

21 Cfr 820
Iso 13485
Iso 14001
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Boston, MA
1,993 Employees
On-site Workplace
Year Founded: 1971

What We Do

Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com.

Similar Jobs

Mondelēz International Logo Mondelēz International

People Lead - SEA MSC Projects & Governance

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Remote
Hybrid
11 Locations
90000 Employees

Mondelēz International Logo Mondelēz International

Plant Finance Controller

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Hybrid
Prai, S.P. Tengah, Pulau Pinang, MYS
90000 Employees

Mondelēz International Logo Mondelēz International

Engineering Intern

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Hybrid
Prai, S.P. Tengah, Pulau Pinang, MYS
90000 Employees

Motorola Solutions Logo Motorola Solutions

Senior Test Engineer

Artificial Intelligence • Hardware • Information Technology • Security • Software • Cybersecurity • Big Data Analytics
Hybrid
Bayan Lepas, Barat Daya, Pulau Pinang, MYS
21000 Employees

Similar Companies Hiring

Mochi Health Thumbnail
Telehealth • Healthtech
San Francisco, CA
70 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees
Stepful Thumbnail
Software • Healthtech • Edtech • Artificial Intelligence
New York, New York
60 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account