• Snapboard
  • Activity
  • Reports
  • Campaign
Welcome ,

Chat with the recruiter

...Minimize

Hey I'm Online! Leave me a message.
Let me know if you have any questions.

Quality Engineer 1

In Georgia / United States

Save this job

Quality Engineer 1   

Click on the below icons to share this job to Linkedin, Twitter!

JOB TITLE:

Quality Engineer 1

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Covington Georgia / United States

JOB DESCRIPTION:

Responsibilities:-

  • Creates investigation files in the Client Global complaint system (Trackwise).
  • Performs complaint investigations for all BMD and OEM manufactured products.
  • Manages completion of assigned complaint investigation files and works with the manufacturing site or suppliers where necessary, to complete the investigation within a timely fashion.
  • Provides support to Project Teams and Quality Department.
  • Creates, reviews and approves Quality System Documents (SOP, CAPA, Audits, SPAs and R002s)
  • Sets up, safely operates, and maintains laboratory equipment and testing instruments.
  • Responsible for all products testing in the Complaint Laboratory in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Develops and maintains a working knowledge of BMD policies and procedures and ISO and FDA requirements and ensures compliance to Department and Division procedures.
  • Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis .
  • May present data findings to peers, engineering and management staff.
  • Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by Company policies
  • Performs tasks accurately and with great attention to detail.
  • Technical competence in testing and writing and responsible for timely notifications based on new information received to FA specialists to meet FDA reporting requirements.
  • Represents the Corporation, Division and Quality Department in a professional manner.

Requirememt:

  • Prior laboratory experience desirable
  • B.S. in Engineering, Engineering Technology, Science a minimum.
  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
  • Experience with Access Databases, Excel (PIVOT Tables and Charts) and complaint handling software (Trackwise or Pilgram)
  • Minimum 1 to 3 years of experience with regulated industry, including co-op/internship experience.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • The requirements included in this job description are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Ability to perform engineering work of a broad nature with little or no direction from Quality Management.
  • Generally, receives guidance on novel or controversial problems.
  • Basic knowledge of medical device regulation, industry or international standard.
  • Broad knowledge of Medical Device complaint reporting requirements.
  • Good laboratory skills, along with a working knowledge of laboratory bench methods and associated equipment.
  • Understanding of laboratory instrumentation.
  • Good understanding of OSHA requirements, Quality Systems Regulations (QSR), Good Laboratory Practices (GLP), ISO, AAMI, and FDA Guidelines, as well as any other regulations/requirements as they pertain to the laboratory.
  • Broad knowledge of manufacturing processes.
  • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
  • Understands Fundamentals of Engineering Principles.
  • Ability to effectively manage time and manage priorities to meet deadlines.
  • Ability to handle multiple task assignments.
  • Ability to interpret Corporate, Division and Department Procedures.
  • Ability to work with minimal supervision.
  • Ability to work in a team.

Position Details

POSTED:

Sep 20, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204865157783786

LOCATION:

Georgia / United States

CITY:

Covington

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Quality Engineer 1    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Responsibilities:-

  • Creates investigation files in the Client Global complaint system (Trackwise).
  • Performs complaint investigations for all BMD and OEM manufactured products.
  • Manages completion of assigned complaint investigation files and works with the manufacturing site or suppliers where necessary, to complete the investigation within a timely fashion.
  • Provides support to Project Teams and Quality Department.
  • Creates, reviews and approves Quality System Documents (SOP, CAPA, Audits, SPAs and R002s)
  • Sets up, safely operates, and maintains laboratory equipment and testing instruments.
  • Responsible for all products testing in the Complaint Laboratory in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Develops and maintains a working knowledge of BMD policies and procedures and ISO and FDA requirements and ensures compliance to Department and Division procedures.
  • Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis .
  • May present data findings to peers, engineering and management staff.
  • Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by Company policies
  • Performs tasks accurately and with great attention to detail.
  • Technical competence in testing and writing and responsible for timely notifications based on new information received to FA specialists to meet FDA reporting requirements.
  • Represents the Corporation, Division and Quality Department in a professional manner.

Requirememt:

  • Prior laboratory experience desirable
  • B.S. in Engineering, Engineering Technology, Science a minimum.
  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
  • Experience with Access Databases, Excel (PIVOT Tables and Charts) and complaint handling software (Trackwise or Pilgram)
  • Minimum 1 to 3 years of experience with regulated industry, including co-op/internship experience.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • The requirements included in this job description are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Ability to perform engineering work of a broad nature with little or no direction from Quality Management.
  • Generally, receives guidance on novel or controversial problems.
  • Basic knowledge of medical device regulation, industry or international standard.
  • Broad knowledge of Medical Device complaint reporting requirements.
  • Good laboratory skills, along with a working knowledge of laboratory bench methods and associated equipment.
  • Understanding of laboratory instrumentation.
  • Good understanding of OSHA requirements, Quality Systems Regulations (QSR), Good Laboratory Practices (GLP), ISO, AAMI, and FDA Guidelines, as well as any other regulations/requirements as they pertain to the laboratory.
  • Broad knowledge of manufacturing processes.
  • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
  • Understands Fundamentals of Engineering Principles.
  • Ability to effectively manage time and manage priorities to meet deadlines.
  • Ability to handle multiple task assignments.
  • Ability to interpret Corporate, Division and Department Procedures.
  • Ability to work with minimal supervision.
  • Ability to work in a team.


Please wait..!!