Process Compliance Manager

At PRC-Saltillo, our mission to provide voices to children, teens, and adults who are unable to communicate effectively with their natural voices. Each year, we provide voices to thousands of individuals through our specialized communication devices, software, and apps. We serve those with autism, cerebral palsy, Down syndrome, ALS, aphasia, and a variety of other medical conditions. Our products not only provide the ability to speak, but open opportunities for education, employment and fuller participation in life.

All applicants need to go to our website to apply www.prc-saltillo.com/careers.

Position Summary: The Process Compliance Manager is responsible for maintaining the compliance processes necessary for adherence to various agency regulatory obligations, including International Organization for Standardization (ISO) for medical device manufacturing including EU Medical Device Regulation (MDR), Food and Drug Administration (FDA) and Accreditation Commission for Health Care (ACHC), in support of the Company’s quality system, objectives, and strategic plan.

Duties and Responsibilities:

• Maintains an efficient quality management system in accordance to the QSMR to ensure that established objectives are met, and prompt corrective action is taken when necessary, including assigning, monitoring, and assisting personnel as needed with corrective and preventative actions (CAPAs), observations (OB), and opportunities for improvement (OFIs).
• Develops monthly reports (CAPA, OFI, and OB) for Leadership Team and produces performance improvement (PI) annual reports.
• Collaborates with other departments and Company personnel to develop and maintain needed processes and ensures procedures are in place and followed.
• Serves as main audit facilitator of FDA, ISO and ACHC external audits and assessments.
• Provides support to product compliance, engineering and product development personnel as needed to ensure adherence to applicable regulatory requirements.
• Serves as main quality management system regulation (QMSR) software contact for implementation, support, training, and improvement activities. Keeps the Company informed on the quality management systems and with process related compliance efforts.
• Serves as the Company’s ISO Management Representative through facilitation of quarterly Management Review meetings.
• Maintains external contacts in areas relating to process compliance, keeping abreast of current requirements and practices, particularly as they apply to risk factors for the Company.
• Performs regular review of relevant compliance process requirements and implements changes needed to maintain the Company’s compliance.
• Provides new hire orientation compliance process training on the quality management system and ACHC compliance for new personnel and departments upon request.
• Perform other duties as assigned.

Required Skills/Abilities:

• Sound analytical and strong organizational skills, the ability to effectively delegate responsibility and coordinate a wide variety of activities.
• Knowledge of quality management systems, manufacturing planning, inventory control, and production processes.
• Knowledge of ISO13485, FDA, ACHC, and European Medical Device Regulation (EUMDR) requirements.
• Excellent written, verbal and interpersonal communication skills.
• Self-starter with ability to work well under minimal supervision.
• Team player with ability to work well with all levels inside and outside the organization.
• Be flexible and able to adjust to rapidly changing circumstances.
• Knowledge of different computer software: Windows, Microsoft Word, Excel, PowerPoint, document control, and enterprise resource planning (ERP).

Education and Experience:

• Bachelor’s Degree in a Quality or Compliance related field is required.
• At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices is required.