Quality Document Control & Compliance Manager (Medical Device)

Job Description

KEY RESPONSIBILITIES / ESSENTIAL FUNCTIONS :

• Manage Document Control staff to ensure all assigned activities are completed and in conformance to cGMP, ISO 13485, and customer requirements
• Assist the Quality Manager in coordinating and executing objectives throughout the company in cross-functional cooperation to maximize product quality and operating systems
• Participate in central compliance and regulatory meetings
• Develop training for shop floor employees to align job roles
• Identify and coordinate resolution of system(s) inefficiencies that contribute to increased quality costs
• Track and trend customer notifications to monitor timely completion and to recognize repeated issues
• Manage CAPAs to ensure all steps are followed to prevent aging
• Incorporate CAPA approach for responses to internal and external audit observation
• Support customer Quality Agreement review from compliance and regulatory standpoint
• Coordinate and support regulatory and customer audits
• Assesses results and effectiveness of Customer Complaint investigations and Corrective Actions for application, validity, and conformance to regulatory, ISO and customer requirements
• Responsible for tracking and trending quality systems KPIs to identify gaps and propose corrective actions
• Execute specific responsibilities as defined within the company quality management system
• Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives
• Represent the Quality Department in support of customer, ISO, and third-party audits
• Carry out managerial responsibilities, in accordance with the organization’s policies and applicable laws. Participates in interviewing, hiring, and training employees
• Other duties as assigned

POSITION REQUIREMENTS :

• Bachelor’s Degree in Sciences or Engineering discipline preferred
• Minimum of 5 years’ experience within the quality profession or a Medical Device Industry
• Minimum 3-5 years' experience in leadership or supervisory role
• Experience working in a manufacturing environment preferred
• Minimum 3-5 years

PREFERRED KNOWLEDGE / SKILLS :

• Excellent communication and or ganizational skills
• Ability to use common software productivity tools, such as Word, Excel and PowerPoint

Qualifications

POSITION REQUIREMENTS :

• Bachelor’s Degree in Sciences or Engineering discipline preferred
• Minimum of 5 years’ experience within the quality profession or a Medical Device Industry
• Minimum 3-5 years' experience in leadership or supervisory role
• Experience working in a manufacturing environment preferred
• Minimum 3-5 years

Additional Information

All your information will be kept confidential according to EEO guidelines.

Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries.

With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.

We put patients first when creating drug delivery devices because we know that accurate dosing and ergonomics contribute to patients completing their treatment.

Working at Nemera means being part of a team that truly enjoys working together and always goes the extra mile to deliver on its commitments.

We’re proud of the work we do because it improves patients’ lives.

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication.

This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.

The Nemera timekeeping system utilizes finger scan. Our biometric policy is available upon request at bghr@nemera.net