Assoc Quality Systems Spec (Hybrid) at Three Point Solutions Inc

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.

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