Post Market Quality Operations Manager Jobs

Experience with complaint management systems

Pre and post-market quality experience for medical devices (preferably class II or higher)

Experience dealing with the FDA and notified bodies

experienced pre/post market quality professional in the medical device field

This position is remote with up to 50% travel (as required).

Implementing a Quality System in alignment with Global internal policies

Participate in ERCOT RMS meetings; Responsible for acting as a liaison with stakeholder subcommittees and working groups;

Advocate LP&L market positions to ERCOT, PUCT, other agencies as it relates to retail competition;

Coordinates ERCOT flight testing with EDI Gateway vendor;

Create SharePoint applications for reference across all departments of Lubbock Power and Light;

Plans, directs, and coordinates activities of the Market Operations support personnel to meet business operations and standards;

Develops and maintains strong working relationships with staff and Market Participants, especially in the Protocol and market guide revision processes.

Min 5-7+ years’ experience in consulting, project management, or a similar field (Retail or Consumer Products preferred).

Proven experience in project management with multiple functions and business partners

Functional expertise in Supply Chain Management (e.g. Logistics, Fulfillment, Sourcing, SC Strategy, etc…)

Collaborate cross-functionally to identify opportunities for improving product, market and channel launch process and planning for future capabilities.

Strong business, leadership, planning and organizing skills.

Experience with new product, market or channel launches strongly preferred.

At least 1-2 years of Supervisory or Management experience.

Effective organization, planning and time management skills.

Apply Risk Management File and Clinical Evaluation content to Post Market Surveillance processes.

Provide proper analysis of product quality, safety, and relatability issues and effective communication to management and other functions as required.

Requirements (Education, Certificates, Licenses, Registrations, Etc.)

Technical writing and presentation skills.

Effective and developed interpersonal skills to interface in a professional manner with all levels of Associates, Management, and Customers.

Job Knowledge, Skills And Abilities

Maintain written and verbal communication with customers and company management on status of NCRs.

Minimum 5 years’ experience in an ISO manufacturing environment - regulated industries preferred.

In-depth Problem Solving and Root Cause Analysis (RCA) skills preferred.

Working knowledge of Lean Manufacturing/Six Sigma/Kaizen preferred.

Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies in a major segment of the company.

Bachelor's degree and 10+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred

Provides general direction to managers, exempt specialists and non-exempt support in various areas, groups and/or operations

Establish Quality Systems that are in compliance with regulatory requirements and meet business needs

Career development with an international company where you can grow the career you dream of

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

Job title: Product Manager Post Market Quality

Job Location : Indianapolis, IN (Remote)

· Agile/ Waterfall methodologies / Software Development Life Cycle (SDLC) process experience

Duration : 12 Months (Possible extension)

You will be responsible to ...

1. Drive business results and customer value

Market Quality or equivalent experience and demonstrated knowledge ofPMQ

DIA Product Manager - Post Market Quality

Experience within Quality and Regulatory focusing on Post

Salesfore, Trackwise (Honeywell), Smarteeva applications

Agile/ Waterfall methodologies / Software Development Life Cycle (SDLC) process

830 Hillview Ct, #280, Milpitas, CA 95035

6+ years of work experience in project management and program development, preferably in an agriculture related field.

Highly organized with excellent time management skills and a proactive results-driven orientation.

Dispute mediation and conflict management skills.

Manage market assignments and reservations for 200+ Greenmarket Producers across 50+ Greenmarket sites, using our purpose-built FileMaker database.

With assistance from the FAA Administrative Senior Advisor, develop and manage FAA’s FileMaker Database system.

Manage 5+ Greenmarket vehicles, with assistance from GrowNYC Fleet Administrator.

3+ years of Quality Management Systems (QMS) Experience

American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred

Timely communication of business-related issues or opportunities to the next management level

Maintain knowledge of current global regulations impacting Post Market Surveillance activities

Apply knowledge to develop and optimize processes and suggest improvements as needed and/or required

Additional responsibilities may be assigned

Minimum 2 years’ experience in Operations Quality Management

Manages various QC/QA program(s)/processes within the department (training, sample management, data review and reporting) and serves as subject matter expert (SME).

BS degree in scientific discipline; and/or equivalent combination of education and experience

Minimum 2 years’ managerial experience

Leads planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification, as required

Manage Supervisors and Technicians to ensure

3+ years of Quality Management Systems (QMS) Experience

American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred

Timely communication of business-related issues or opportunities to the next management level

Maintain knowledge of current global regulations impacting Post Market Surveillance activities

Apply knowledge to develop and optimize processes and suggest improvements as needed and/or required

Additional responsibilities may be assigned