QC Manager
American Cybersystems, Inc.

Job Info

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An Innova Solutions Client is immediately hiring for a QC Manager

Position type: Full-time/Direct Hire

Location: Charleston, SC

Must have med device exp
Must have managed people
Must have engineering or science degree
Must have QC experience.

Job Description:

Responsibilities

• The Quality Control Manager is responsible for supporting the effectiveness and quality of product tested in Quality Control (QC) Lab, effective investigation and execution of the non-conforming material (NCMR) process, effective investigation and execution of the complaint handling process, and continuous improvement activities.
• This person must be able to lead a team focused on the activities defined above
• The job holder ensures the applicable tools, techniques, and methodologies are used according to the company's needs and applicable regulations
• Oversee the work of assigned team within the QC Lab including responsibilities on transfer, projects within manufacturing in collaboration with key stakeholders, oversee qualification of lab equipment, the development and validation of laboratory test methods in support of production and/or new product/process development
• Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope, and objectives
• Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
• Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards and guidelines
• Lead in the monitoring and publishing of QC Lab metrics for the organization
• Facilitate team to ensure laboratory specific investigations are performed in compliance with quality and regulatory requirements
• Provide Quality Operations support in cross-functional workstreams leading to continuous improvement (e.g., Lean Six Sigma)
• Effectively transfer and implement the Complaint Handing process.
• Oversee the timely and effective execution of the complaint investigations
• Lead in the monitoring and publishing of Complaint Process metrics for the organization
• Effectively execute the non-conforming material (NCMR) process.
• Oversee the timely and effective execution of the NCMR investigations
• Lead in the monitoring and publishing of NCMR Process metrics for the organization
• Supervisory Responsibilities: Manage a team of 3 ( 1 QC Lab Supervisor and 2 QA Engineers)Oversee Quality Operations resources that the QC Lab, NCMR process and Complaint Handling process.
• Performs other related duties as assigned

Qualifications

• A Bachelor's degree in science or engineering discipline (mechanical, industrial, biomedical, chemical engineering, material/life science) is required At least 5 years' work experience in a in regulated environment (medical devices/diagnostic instrumentation industry, pharmaceutical or biotechnology industry) Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testing
• Test method validation and transfer cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC Statistical methods Attention to detail

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Thank you!

Preeti Sehgal

preeti.sehgal@innovasolutions.com

PAY RANGE AND BENEFITS: Pay Range*: $120K - $135K per year

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits:

• Benefits provided by client as this is a Direct Hire position

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Website: https://www.innovasolutions.com/

Recent Recognitions:

• Named One of America's Best Employers for New Grads by Forbes (2024

• Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)

• One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)

• One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)

• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)

• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)

• AWS Advanced Tier Services Partner with 100+ certifications

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran

status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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