Demo

Assoc Quality Systems Spec (Hybrid)

Three Point Solutions
North Haven, CT Full Time
POSTED ON 1/30/2025
AVAILABLE BEFORE 4/28/2025

Job Title : Assoc Quality Systems Spec (Hybrid)

Client : Medical Device Manufacturing Company

Duration : 8 Months

Location : North Haven, Connecticut 06473

Shift : 1st Shift (Hybrid (4 days in the office, 1 remote)

Technical Skills

Must Have :

  • Competency in Microsoft Productivity Suite
  • Fluent Communication with internal contacts with immediate group

Nice To Have :

  • Knowledge of 21 CFR Part 820 - Quality System Regulation
  • Knowledge of Atlassian products; JIRA specifically
  • Knowledge of or experience with Medical Device Quality System, ISO 13485, and Risk Management, ISO 14971, requirements
  • HM's Top Needs :

  • Have the ability to handle multiple activities within a given work week
  • Effectively and professionally communicate to Quality leadership and cross-functional peers
  • Demonstrate self-accountability and autonomy with minimal oversight once trained
  • Scope of the Role :

    The position is entry level. The scope will support the Robotic Surgical Technologies post-market Quality organization with management of :

  • Scoping and Bounding for post-market inquiries
  • Reconciliation and disposition of product returns and product hold orders
  • Completing queries for sales, distribution and post-market events
  • Education :

  • Bachelor degree
  • Yrs Experience : 0 - 3 yrs

    Work Week : 40 hrs

    Work Location : On-site in North Haven, CT; may be

    Responsibilities may include :

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and / or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Prepares reports and / or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.
  • Specialist career stream :

  • Typically an individual contributor with responsibility in a professional discipline or specialty.
  • Delivers and / or manages projects assigned and works with other stakeholders to achieve desired results.
  • May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
  • Differentiating Factors :

  • Autonomy : Entry-level individual contributor on a project or work team. Works with close supervision.
  • Organizational Impact : Delivers work of limited scope, typically smaller, less complex projects or related activities.
  • Innovation and Complexity : Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
  • Communication and Influence : Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
  • Leadership and Talent Management : N / A - job at this level is focused on self-development.

    Required Knowledge and Experience : Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A), 0 years of experience required.

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Assoc Quality Systems Spec (Hybrid)?

    Sign up to receive alerts about other jobs on the Assoc Quality Systems Spec (Hybrid) career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $75,024 - $92,682
    Income Estimation: 
    $97,718 - $119,022
    Income Estimation: 
    $102,000 - $128,790
    Income Estimation: 
    $63,136 - $79,042
    Income Estimation: 
    $78,244 - $97,353
    Income Estimation: 
    $78,244 - $97,353
    Income Estimation: 
    $99,704 - $121,947
    Income Estimation: 
    $99,704 - $121,947
    Income Estimation: 
    $124,827 - $154,865
    Income Estimation: 
    $122,125 - $158,955
    Income Estimation: 
    $166,313 - $206,719
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Three Point Solutions

    Three Point Solutions
    Hired Organization Address Johnston, IA Full Time
    Job Description Job Description Job Title : License & Sales Management Specialist / Customer Service Representative III ...
    Three Point Solutions
    Hired Organization Address Waterloo, IA Full Time
    Job Description Job Description Job Title : Lead Tour Guide / Coordinator, Group Tour and Customer Visits - Events Plann...
    Three Point Solutions
    Hired Organization Address Ankeny, IA Full Time
    Job Description Job Description Job Title : Material Coordinator II - Material Planning and Control Client : Heavy Machi...
    Three Point Solutions
    Hired Organization Address Canton, IL Full Time
    Job Title : Project Coordinator (100% Remote) Client : ATM Machine Manufacturing Industry Duration : 1Year Contract Role...

    Not the job you're looking for? Here are some other Assoc Quality Systems Spec (Hybrid) jobs in the North Haven, CT area that may be a better fit.

    Assoc Quality Engineer

    PSG Global Solutions, North Haven, CT

    Assoc Director, Quality Assurance/Quality Control

    Yale School of Medicine, New Haven, CT

    AI Assistant is available now!

    Feel free to start your new journey!