Associate Director Quality Assurance

The Associate Director, Quality Assurance, is responsible for the global strategic management and oversight of R&D Quality activities and associated staff related to Good Manufacturing Practices (GMP) for non-Energy Based Devices (EBD) and EBD Medical Devices. Activities include, but not limited to general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control, etc. This role will operate as a liaison among the various R&D functions and the Quality Operations department to assure global strategic alignment and compliance.

Major Duties

1 Staff Management
Responsible for the management of global R&D Quality staff including performance management, training, coaching, mentoring, and task oversight

2 R&D Quality Management and Oversight
Responsible for the global strategic oversight of R&D Quality GMP activities as related to Medical Devices (non-EBD and EBD) in support of Project Teams and R&D overall to assure global compliance. Including:
* Quality activities for medical device manufacturing and Design &
Development activities throughout all stages of the device development process (e.g. general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control).
* Leading teams through Design Control requirements while maintaining compliant Design History Files and support tech transfers to manufacturing.
* R&D quality oversight of preclinical and clinical planning and readiness activities.
* R&D quality oversight of document reviews and regulatory submissions in support of business objectives.
* Oversee R&D Quality project timelines as defined by department, project team, and business objectives.

3 Quality activities for medical device manufacturing and Design &

Risk Management
Oversee risk management activities throughout all stages of the device development process.
* Oversee the risk management plan, risk file and risk report for assigned projects.

4 Human Factors Engineering
Oversee human factors/usability activities throughout all stages of the device development process.
* Oversee the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and report.

5 Audits
Oversee audits (e.g., internal, vendor/supplier), as needed.
* Vendors/suppliers qualifications.
* all company regulatory authority inspections and certification body audits, as applicable.

6 General R&D Support
Support R&D related activities including but not limited to SOP creation and maintenance, NCRs, DCNs, CAPAs, deviations, change requests, archival, corporate, and departmental initiatives.

7 R&D Quality Improvements
Facilitate and support harmonization initiatives within the R&D group.
* Facilitate and support projects to improve R&D compliance and operational efficiencies.

8 Quality Intelligence
* Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliant as related to Medical Devices.
* Provide updates to R&D staff, as applicable.

9 Further Tasks
Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriate.
* Provide support to other R&D staff as needed and perform duties and assignments as required.

10 Other duties as assigned
Additional duties as needed to support the business and overall company objectives.

Leadership Responsibilities

Articulate a clear and compelling vision aligned with the global cultural tenets and strategic objectives of the company.
Clearly define roles and responsibilities while holding members accountable for their performance.
Develop talent and skills of individual team members
Empower leaders and employees to make informed decisions, enabling autonomy while providing guidance and support.

Education
Bachelor’s Degree in Engineering or Life/Health Sciences
Preferred: Master's Degree

Additional Licenses and Certifications
Certification(s) – ASQ Certified Quality Engineer or equivalent - preferred

Technical & Functional Skills
Proficient in all MS Office applications
Demonstrated organizational skills, ability to independently prioritize work and detail oriented
Strong verbal, written communication, and emotional intelligence skills
Ability to effectively multitask and manage multiple projects
Experience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferred.
Knowledge of regulatory requirements and standards for a medical device organization (i.e., 21CFR820, ISO 13485, ISO 14971, IEC 62304)
Ability to work effectively in a global, matrix environment
Ability to travel up to 15%

Physical Requirements
This job requires various physical activities and environmental conditions that employees must be prepared to handle. Key physical requirements include standing, sitting, walking, and bending, with tasks involving repetitive movements and handling objects of different weights, ranging from light (under 5 lbs) to heavy (over 20 lbs). Employees will also need to operate machinery such as computers, copiers, and telephones, and perform tasks requiring manual dexterity and visual acuity. The working environment may expose employees to different temperatures, noise levels, and other conditions like humidity and heights. Sensory requirements include near and far visual acuity, color discrimination, hearing, and speech. Additionally, some roles may involve local, national, or international travel (up to 20%). These requirements ensure that the job is performed effectively while accommodating employees’ needs in compliance with the Americans with Disabilities Act (ADA).

Work Experience
7 - 8 years of relevant Quality medical device development experience
Energy-Based Device Experience
Knowledge of Class II, 510K, 21CFR 820, ISO 13485, IEC 606011, ISO 14971 experience

Pay Rate Range: $40-50/hr depending on experience