Quality Systems Program Mgr

Summary of Role: 
 

Develops, implements, and maintains an organization's quality management system (QMS), ensuring compliance with standards and regulations through policies, audits, and corrective actions (CAPA). They lead cross-functional teams, manage document control, oversee vendor quality, and use data analysis to drive continuous improvement, ensuring products/services consistently meet customer and company quality goals. 
 

Responsibilities:

• Responsibilities may include the following and other duties may be assigned. 
• 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. 
   

Shift: 40 hrs usually between 1 and 2 shift (8:30-5:30)
 

Location: Juncos, PR

Education: Engineering degree (prefertrable); Sciences
 

Preferred Qualifications: 

•  Hands on Experience on Projects/Scheduling for Medical Device manufacturing
•  Excellent Negotiating and Communication Skills
•  Risk Management/Critical Thinking
•  Conflict Resolution skills
•  Knowledge in Medical Devices regulations 

Skills:

• Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets . Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management. 
• Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties . Modifies programs management processes to improve program.
•  Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management.
•  Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.

This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: Echo Consulting Group Inc