Quality Manager- Medical Device

Eastridge Workforce Solutions is collaborating with a prominent Medical Device manufacturer, based in Phoenix, AZ, renowned for its commitment to delivering effective solutions to clients and improving patient care.

Position Overview:

We are seeking a talented and experienced Quality Manager- Medical Device to join our client's team. The Quality Manager- Medical Device will be responsible for developing, implementing, and directing quality assurance activities and programs, focusing on overall quality management, compliance, process validation, good manufacturing practices, and post-market support. If you are excited about contributing to a dynamic and innovative company, we invite you to apply for this challenging and rewarding opportunity.

Key Responsibilities:

• Document and report on the effectiveness of company processes to management.
• Establish and maintain the Company Quality Management System (QMS) in coordination with cross-functional teams, ensuring compliance with applicable regulations.
• Develop and execute quality strategies and systems in line with Good Manufacturing Practices and other relevant regulations.
• Lead quality strategy development, quality planning, and risk management activities.
• Develop quality assurance specifications, test methods, sampling plans, and inspection acceptance criteria.
• Provide leadership in the use of data analysis tools and ensure internal QMS audits are conducted in accordance with regulations.
• Administer and maintain the electronic Quality Management System.

Qualifications:

• Bachelor's Degree in Engineering or related engineering field; or equivalent work experience.
• Minimum of 8 years in a quality engineering role in the Medical Device field or related industry preferred.
• Experience with FDA inspection and ISO audits is desired.

Ideal Candidate Skills and Abilities:

• Commitment to Quality
• Knowledge of the standards related to Medical Device manufacturing, including ISO 13485, 21 CFR Part 820, and ISO 14971 preferred
• Understanding of design control, disciplined product development processes, regulatory, and quality requirements
• Experience with sterile manufacturing and packaging is preferred
• Solid analytical skills and capable of adapting industry practices to unique situations
• Working knowledge of common quality tools
• Excellent verbal and written communication skills
• Team-oriented individual with strong interpersonal skills, management and leadership skills
• Solid analytical skills and the ability to problem solve quickly
• Skilled in Microsoft Office (Word, Excel, PowerPoint, and Outlook)
• Proven ability to set and achieve strategic objectives
• Ability to work with Executive Management to create company objectives
• Entrepreneurial, adaptable and innovative approach to planning
• Ability to collaborate with diverse groups of people
• Positive attitude, driven and self-directed

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds.

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