Quality Manager - Fix term Contract

Regulatory Jobs; New Jersey; On-site; USD 95,000 - 140,000; Full time

Job summary

Convatec seeks a Quality Management professional to manage the Quality Management System for a fixed-term contract (~1 year) with possible extension. You will lead the quality team, oversee CAPAs and investigations, and ensure compliance with QMS regulations across audits and product areas.

The role requires strong leadership, proactive problem solving, and travel ~30%. English and Spanish at advanced level are required to support global activities and regulatory interactions.

Qualifications

• Two (2) years in regulated industries.
• 1 year experience in management/principal/Sr. Engineering positions (preferred).
• Experience in leading front or back rooms during external regulatory body audits.
• Experience leading external audits in sister plants (preferable).
• Experience with submitting Local Registrations (preferable).
• Experience leading investigations of audit findings (preferable).
• Experience in executing training programs (preferable).
• Experience with QMS regulated software.
• Knowledge of change control principles, quality systems, training, standards, and regulations of Medical Device Quality systems.
• Demonstrated proficiency in complaints, non-conformance and CAPA management.

Responsibilities

• Supervise the Quality team and their support to all relevant product categories.
• Assist and coach the teams in conducting investigations of trainings, document activities, complaints, nonconformities and corrective/preventive actions.
• Oversee the complaint system, assuring evaluations and investigations are completed in a timely manner, trends are analyzed, and actions are executed (CAPAs, SS, HHE).
• Report progress of investigations for complaints, nonconformities, CAPAs, internal/external audits, stop shipments, HHEs and other Quality System requirements.
• Oversee the CAPA system, ensuring investigations, corrections, containment, and actions are taken and effectiveness is measured.

Skills

Quality management

Leadership

Regulatory audits

CAPA management

QMS software

Root cause analysis

English Advanced

Spanish Advanced

Project management

Education

Bachelor’s degree in industrial engineering or business administration

Tools

QMS software

Audit tools

Job description

This is a fixed term contract opportunity that is expected to last approximately one year with the eligibility for extension.

Position Overview:

This function is responsible for the management and oversight of the Quality Management System. Responsible for developing, identifying, analyzing, and improving the quality management system. This process will follow the Convatec Quality Management Systems, Unomedical Quality System, and all applicable regulations and standards (e.g. Quality Management System Regulation - QMSR, ISO13485, Japan MO-169, Brazil ANVISA).

The position requires empowerment and proactivity, time management skills, organization, and attention to detail. The role will have interaction and/or communication, when applicable, with employees, customers, suppliers, third parties.

Key Responsibilities:

• Supervise the Quality team and their support to all relevant product categories.
• Assist and Coach the teams in conducting investigations of Trainings, Document activities, complaints, nonconformities and /or corrective preventive actions.
• Oversee the Complaint system, assuring corresponding evaluations and/or investigations are completed in a timely manner, trends are analyzed, and applicable actions are executed (e.g. CAPAs, SS, HHE)
• Report progress of investigations for complaints, nonconformities, preventive/corrective actions, internal/external audits, stop shipments, HHEs and any other applicable Quality System requirement.
• Oversee the CAPA system, assuring corresponding investigations, corrections, containment, and corrective/preventive actions are taken, as well as insuring that their effectiveness is measured; this while also maintaining a system that complies with QMS requirements.
• Oversee the Training and Document Management system, assuring corresponding activities, trainings, evaluations and/or investigations are completed in a timely manner, trends are analyzed, and applicable actions are executed.
• Execute/report/Analyze trend analysis related to the quality management system.
• Participate in local and/or corporate meetings representing the site Quality System and communicating any action/activities that are needed.
• Oversee/prepare corresponding reports and/or meeting (e.g. trend analysis, management reviews) to assure the Quality System is robust and complies with requirements, and, if applicable raise corresponding action to keep in compliance.
• Lead external audits and certification program, if needed.
• Support and participate in company projects.
• Identify, develop, and implement continuous improvement projects for products and processes.
• Carry out, together with your team and if required, CAPA (Corrective and Preventive Actions).
• Follow and enforce the corresponding policies and procedures, implementing solutions aligned to the needs of the business and its products.
• undefined

Authority (if applicable):

This role has signatory rights as listed on Quality Management systems records and procedures

Skills & Experience:

• Two (2) years in regulated industries
• 1 year experience in management/principal/Sr. Engineering positions (preferred).
• Experience in leading front or back rooms during external regulatory body Audits.
• Experience leading external audits in sister plants (preferable).
• Experience with submitting Local Registrations (preferable).
• Experience leading investigations of Audit finding (preferable).
• Experience in execution training programs (preferable).
• Experience with QMS regulated software.
• Knowledge of change control principles, quality systems, training, standards, and regulations of Medical Device Quality systems.
• Demonstrated proficiency in complaints, non-conformance and CAPA management.
• Skill on root cause, continuous improvement, and statistical tools.
• Strong motivation to achieve good results is essential. Self-directed leadership, requiring minimal supervision and proactive attitude.
• undefined

Qualifications/Education:

• Bachelor’s degree in industrial engineer, business administration (desirable) or any other related grade.
• Knowledge of the Quality Assurance standard for medical devices like ISO13485 and QMSR.
• Knowledge of root cause analysis tools.

Team

Quality applicable personnel.

Principal Contacts & Purpose of Contact

• Internal: Directors, Managers, Engineers, and Supervisors (all departments)
• External: Directors, Managers, Specialists, Engineers, Supervisors (other manufacturing locations). External auditors, Global Complaint Handling Unit, Global CAPA Handling unit (all departments).

Travel Requirements

You will be expected to travel an estimated 30% of the time, mainly to different Convatec plants (depending on business requirements).

Languages

• Speaking: Yes English and Spanish Advanced Required
• Writing/Reading: Yes English and Spanish Advanced Required

Working Conditions

• Office Working.
• EH&S requirements are established in local procedures.
• Employee will not be exposed to any chemicals
• Maintain general awareness of the CVT’s EHS policy and supporting standards.
• Understand EHS risks and applicable legal requirements associated with their job responsibilities and the appropriate controls in place to manage those risks and requirements.
• Carry out job responsibilities with due professional care and in compliance with legal requirements and internal standards without compromising their own safety or that of others.
• Be alert to EHS hazards in the workplace, responding to them as appropriate and communicating them to responsible management as they are identified (e.g., spills).
• Participate in training, awareness, and community initiatives as appropriate.
• Help drive continuous EHS performance improvement by suggesting potential improvements to responsible management.

Special Factors

• Working flexibly.
• Willingness to work weekends, if required.

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Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

About Convatec

Pioneering trusted medical solutions to improve the lives we touch:

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.