JT771 - QUALITY SYSTEMS PROGRAM MANAGER

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.

In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities :   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 company's mission globally.

Is accountable for overall program process, performance, and customer satisfaction.

Provides input to establishing program objectives, timelines, milestones, and budgets.

Recommends new policies and procedures that affect program management.

Qualifications : Bachelor's degree in engineering (preferably) 5+ years of relevant experience Experience in medical device design, development & manufacturing.

Experience of products with electrical functionality an advantage.

Proven project execution.

Hands on experience on Projects / Scheduling for Medical Device manufacturing.

Critical thinking and PM skills.

(e.g.

project planning, communication, risk management, etc.) Decision making, conflict resolution, negotiating and communication skills.  Ability to lead, work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution.

Ability to lead team to define goals, provide solutions and align on path forward, drive / track / communicate progress, adapt as needed with team.

Ability to read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.

Knowledge of scientific problem-solving methodologies.

(e.g.

DMAIC, process map, 5 whys, Is / Is not, etc).

Ability to ensure work meets required standard (compliant to quality management system, grounded in scientific facts and / or data, within safety / scope / schedule / cost guidance).

Knowledge in Medical Device regulations.  Ability to understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges.

Available to work 1st Shift, 2nd Shift (40 hours between 8 : 30am - 5 : 30pm).

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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