Quality Manager

The Quality Manager in our Spartanburg, South Carolina facility is responsible for leading quality improvement for an Applied Sterilization Technologies (AST) processing or labfacility. This position leads implementing and maintaining state-of-the-art quality practices andassumes overall responsibility in ensuring that the site maintains operational and quality systemsin a state of compliance to domestic and international standards.

As a Quality Manager you are 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 producton hold that is identified as potentially non-conforming and escalating as needed for additionalreviews by technical teams.

This position requires working onsite in our Spartanburg, South Carolina facility.

• Lead the organization’s Quality staff to ensure compliance to the overall QualityManagement System and drive continuous improvement.
• Lead the organization’s Quality staff to ensure alignment to operations, support Leanefforts and drive quality improvement for services/processes.
• Work closely with site senior management to provide strategic direction and developmentof 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 ManagementReview process.
• Ensure compliance with appropriate domestic regulatory and international standards andrequirements.
• Lead the organization’s continuous improvement process; including data analysis,improvement projects and process capability to improve key metrics as measured by theproduct/service quality dashboard.
• Lead and implement effective production and process controls.
• Manage the CAPA, complaint and non-conformance handling processes to insurecustomer responsiveness and process improvements.
• Lean and manage Regulatory Agency and Notified Bodyinspections and drive the creation and implementation of sustainable and effectiveremediation plans.
• Oversee the completion of Customer audits.
• Apply regulatory knowledge and judgment to the evaluation of quality concerns andregulatory 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 requirementsare met according to documented policies, procedures, standards and regulations.
• The position requires a level of authority to conduct and direct required activities such asquality planning, personnel management and regulatory compliance.
• Perform other duties as assigned.

Required:

• Bachelor’s Degree in a related scientific/technical field
• Minimum of 2 years of experience in a Quality leadership role.
• Minimum of 10 years of experience working in an ISO certified environment required.
• Minimum of 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum of 10 years of experience in manufacturingor processing environment or another technical/scientific field.

Preferred:

• Minimum of 10 years of experience with medical device or other regulated industries preferred.
• Sterilization experience preferred.
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
• Ability to build relationships and collaborate cross functionally to achieve business goals.

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 working familiarity of MS Office applications includingExcel, 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.

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

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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