Senior Manager, Quality Operations

Looking to take your career to the next level? Our client is a market leader and innovator in the development and supply of world-class automated immunohistochemistry instrumentation, along with a full range of reagents for IHC/ISH lab testing. They are looking for a Quality Manager to lead the quality team in charge of reagent manufacturing. This is a critical role for the organization and requires someone who can take initiative, lead others, and drive improvements. If this is you, apply now.

Quality Manager – Reagents Responsibilities:

• Lead the Quality team and optimize performance.
• Oversees and maintains the system to evaluate the level of cGMP compliance.
• Utilize quality principles to improve the operations process.
• Participate in CAPA's, ISO Audits, and manage the non-conformance program.
• Notifies senior management of potential quality issues that might impact product quality
• Facilitates risk management and hazard analysis discussions.
• Provides input into Quality Management Reviews.

Quality Manager – Reagents Requirements:

• Biochem background with experience in reagent manufacturing.
• 5+ Years of experience leading a manufacturing quality team is required.
• Experience with QA manufacturing for medical devices involving electromechanical/electronic technology is required
• Experience with ISO 14971, ISO 13485, and 21 CR 820.
• Risk management experience preferred
• Self-motivated, independent, and able to prioritize and manage multiple projects.
• Disciplined and organized with excellent attention to detail
• Exceptional communication skills in written and verbal format along with the ability to gather, understand, and utilize data to drive decision-making.

Quality Manager – Reagents Benefits:

• Salary: $140K – $160K
• Medical, dental, vision, life, and disability insurance
• 401k match
• Supportive, friendly, and entrepreneurial culture!

At Goodwin Recruiting we are committed to our core values. We take our value, Dedicated to Diversity & Inclusion, very seriously and will never discriminate against a candidate or client based on any protected classes. Our clients seek qualified candidates, and that is what we deliver. A person’s age, gender, race, sexual orientation, gender identity, national origin, veteran or disability status, or arrest or conviction record has no bearing on whether he, she, or they are able to do the job. We evaluate the knowledge, skills, and abilities that meet the requirements of the position and aim to open doors and change lives. We value all people, understanding that uniqueness and diversity foster a stronger team that is innovative and brings varying perspectives to the table. We put our money where our mouth is and are proud of our efforts to identify a broad slate of candidates, with many hiring success stories to share.