Quality Systems Manager

The Quality Manager is responsible for leading quality improvement for an AST processing or lab facility. This position leads implementing and maintaining state-of-the-art quality practices and assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards.

The role is responsible for the organization, documentation, and maintenance of the quality system to be compliant with, as appropriate, the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role leads the local site efforts focused on quality system improvement, supplier quality, process quality, new service/modality/technology development quality and quality system compliance. The Quality Manager serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards.

The Quality Manager has the responsibility, duty, and decision-making authority to put any product on hold that is identified as potentially non-conforming and escalating as needed for additional reviews by technical teams.

• Lead the organization's Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
• Lead the organization's Quality staff to ensure alignment to operations, support Lean efforts and drive quality improvement for services/processes.
• Work closely with site senior management to provide strategic direction and development of the organization's quality strategies and tactics.
• Provide quality viewpoints and opinions on future service/technology offerings.
• Provide coaching, mentoring and leadership to the Quality staff.
• Serve as the site's Management Representative and lead the organization's Management Review process.
• Ensure compliance with appropriate domestic regulatory and international standards and requirements.
• Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
• Lead and implement effective production and process controls.
• Manage the CAPA, complaint and non-conformance handling processes to insure customer responsiveness and process improvements.
• Responsible for successfully leading and managing Regulatory Agency and Notified Body inspections and driving the creation and implementation of sustainable and effective remediation plans. Responsible for overseeing completion of Customer audits.
• Apply regulatory knowledge and judgment to the evaluation of quality concerns and regulatory compliance issues.
• Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections, and/or continuous improvement initiatives.
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards, and regulations.
• The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management, and regulatory compliance.
• Perform other duties as assigned.
  
  

Required:

• Bachelor's Degree (Engineering or related technical field).
• Minimum 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum 10 years of experience with medical device or other regulated industries preferred.
• Minimum 10 years of experience working in an ISO certified environment required.
• Minimum of 2 years in a Quality leadership role.

Preferred:

• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.

Other:

• Excellent problem-solving skills.
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Effective interpersonal skills, ability to work independently under minimal guidelines andsupervision.
• Demonstrated excellent organizational, oral, and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Ability to work in a fast-paced, regulated environment with strict deadlines and ever-changing responsibilities.
• Mathematical skills including practical application of fractions, percentages, ratios,proportions and algebra.

#LI-HT1

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

Here is a brief overview of what we offer:

• Market competitive pay
• Extensive paid time off and (9) added holidays
• Excellent healthcare, dental, and vision benefits
• Long/short term disability coverage
• 401(K) with company match
• Maternity and parental leave
• Additional add on benefits/discounts for programs such as pet insurance
• Tuition reimbursement and continued educational programs
• Excellent opportunities for advancement in a stable long-term career