Quality Manager

Proclinical is currently recruiting for a Quality Manager for a biotechnology company located in Needham, MA. Successful candidate must possess the ability to work very independently, willingness to learn and adopt, initiative, communication and drive are important.

Job Responsibilities:

• Conduct meetings to review status of key QMS indicators and performance, issues periodic reports to management.
• Ensure the creation, maintenance, and compliant execution of a Quality System to support medical devices in accordance with FDA 21 CFR 820 and ISO 13485.
• Manage the site Quality Manual and executing on internal Quality Systems including Document Control, Internal Audits, CAPA, Management Review, Complaint Management, Change Control, etc.
• Develop and provide quality-related training to all team members throughout the employee life cycle (new hires/onboarding, transfers, and annual/continuing education and training).
• Ensure supplier quality including audits, negotiating Quality Agreements, Supplier Corrective Actions, non-conformances, and other supplier oversight activities.
• Plan, develop, and approve verification and validation activities, work in conjunction with Product Development and Manufacturing.
• Ensure Compliance with policies and procedures.
• Serve as point of contact for customer quality audits.
• Provide quality system performance reports to management.
• Develop and maintain Customer Complaint System.
• Develop and maintain Quality Policy Manual, QMS elements e.g. document control, change control, quality records, corrective & preventive actions etc.
• Develop and perform QMS training for employees.
• Host customer & regulatory audits as required.
• Identify and recommend opportunities for Improvement.
• Set goals for continuous quality improvement and customer satisfaction.
• Develop and maintain customer complaint system to ensure complaints are investigated and resolved in a timely manner.
• Develop and implement policies and procedures to ensure compliance with regulatory requirements.
• Direct and obtain company and product registration with USFDA and other governing bodies, including ISO 13485 Certification.

Skills and Requirements:

• Bachelor's degree in science or engineering with 3-5 years of experience in quality systems/quality assurance in the medical device industry is preferred.
• Quality management system implementation.
• Must have analytic experience.
• Knowledge, experience, and leadership skills.
• Excellent presentation skills, strong interpersonal and teamwork skills.
• Ability to collaborate and meet timelines.
• Proficiency in MS-Word, Excel, and PowerPoint.
• An in-depth knowledge of medical device regulations is required.
• Requires demonstrated ability and desire to create, implement, and optimize a compliant quality system.
• Must have a demonstrated ability to plan, organize, and self-direct toward company goals in a rapid and effective manner.
• Prior knowledge of company, industry, and governmental regulations affecting medical device product and process quality.
• Experience with FDA audits is preferred.
• Strong interpersonal skills including a proven track record of building and maintaining effective working relationships with teams and industry partners.
• Proficiency in MS-Word, Excel, and PowerPoint.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brandy Plumb at (+1) 646-367-2745 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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