Product Manager Post Market Quality Jobs

Basic understanding of project management principles and the ability to contribute to the execution of complex projects

Collaborate with the PTM Operations Manager to maintain and update product development calendars, ensuring adherence to timelines

Collaborate and provide updates and insights to relevant Global Product Executives and Senior Managers

Minimum 2+ years of experience in operational coordination and project support within a collaborative team environment

Effective communication skills, including the ability to assist in creating clear and impactful presentations

Strong analytical and organizational skills with keen attention to detail

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

4+ years of experience leading projects, which includes business, product management, QA Objectives

Leadership skills to effectively manage and grow a team.

Bachelor’s Degree in Engineering, or equivalent experience required

ASE Master Certification (A1-A8) / Advance Engine Performance (L1) desired

8-10 years as a manager in Automotive industry providing direction for supervisors/managers and exempt employees

Strong technical acumen with excellent analytical and problem solving skills

6+ years of experience as a product manager / Sr. product manager or a product owner in enterprise saas software

Manage cross-functional team communication with business, design and engineering to prioritize, design, and define product functionality

Write clear and actionable product requirements

Ability to communicate product ideas, requirements and business plans to all levels of the organization

Excellent communication and presentation skills, with the ability to articulate complex ideas and concepts to both technical and non-technical stakeholders.

Blend of analytical skills and user empathy, with the ability to drive product decisions that incorporate quantitative and qualitative insight

Expertise in project management, effectively delivering complex projects on time.

Demonstrated analytical capabilities and organizational skills.

Manage PTM Processes and Ways of Working

4+ years of successful experience leading moderate to complex operations and projects collaboratively across teams.

Strong communication skills, including the ability to create visually-compelling presentations.

Experience in building effective teams and fostering cross-team collaboration.

Monitor compliance to respective Quality Agreements and escalate issues to respective Supplier Relationship Manager and senior management, when necessary.

Coordinate development of Annual Product Reviews and FDA metrics for designated product(s) and ensure completeness including lifecycle management commitments.

Working knowledge of batch release processes and associated accountabilities (assessment of batch data, deviations, investigations, change controls, complaints, etc.).

Knowledge of cGMP and regulatory requirements for ADC manufacturing and testing.

Acquire and maintain end-to-end product knowledge enabling a contextual understanding of designated product(s) from development through current day.

Partner with relevant teams to highlight potential quality issues during development, manufacturing and testing and identify/execute strategies to effectively manage them.

5+ years in customer experience product management or equivalent experience, developing and launching products with highly successful business outcomes at scale

Exceptional problem-solving skills using first principle thinking, with demonstrated faculty to make sound decisions by accurately evaluating trade-offs

Demonstrated ability of strong leadership, organizational and execution skills in a fast-paced environment

Experience with SQL or any procedural programming language with the willingness to master them

Solve problems by analyzing data and by implementing product driven and automation solutions

Define and analyze metrics to inform the success of a product and develop action plans accordingly

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

Knowledge about the product management discipline

Lead the regional sales meeting from a product management point of view - secure the agenda for the Product Management scope

Comply with Satair Group's mission, values and Quality Management procedures

Support development effort of new business capabilities

Identify and offer suggestions to improve efficiency

Good analytical skill; ability to see the bigger picture and derive mid to long term recommendations on way forward

Maintain Inspection Readiness and support management during inspections by competent authorities. Ensure all regulatory audit findings are formally closed out.

Manage the quality elements of the Supply Chain including the quality relationship with the third-party contactors.

10+ years of pharmaceutical, medical device, or drug-device combination product quality experience.

Direct experience in finished product dispositioning including review of manufacturing and packaging batch records as well as analytical/microbiological testing results.

Experience in Quality Control and/or Design Control is strongly preferred.

Job Title: Pharmaceutical Product Quality Manager

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