
Sr. Quality Manager
- Huntsville, AL
- Permanent
- Full-time
- Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products.
- Responsibility to maintain compliance to all applicable regulatory standards.
- Sanmina primary representative for supporting all Regulatory investigations and audits from the FDA, Regulatory Bodies and Customers.
- Participates in the reviewing of engineering designs to contribute quality assurance requirements and considerations.
- Assists product support areas in gathering and analyzing data. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
- Perform Internal and Supplier Audits.
- Responsible for new Supplier qualification per Sanmina's process and procedures.
- Management Representative responsibilities for the QMS.
- Achieve various certifications for the organization as the need arises (ex. IATF 16949).
- Drive supplier quality corrective actions and continual improvement.
- Maintain records and data trending for all areas of responsibility as applicable.
- Manage and continuously develop the Quality and Regulatory team that supports all the above duties and responsibilities.
- Actively engage all interdependent business functions (Engineering, Operations, Program Management, Finance, Sales) in support of holistic success.
- Monitor and maintain compliance to International Traffic In Arms Regulations ( ITAR), Export Administration Regulations (EAR) 15 CFR Parts 730-774, and Customs-Trade Partnership Against Terrorism (CTPAT) Security requirements and regulations as appropriate.
- BS in a related Engineering discipline
- 7+ years experience as a Quality Manager/Leader; familiarity with outsourcing and contract manufacturing, dealing with complex electro-mechanical assemblies and sub-assemblies is a plus.
- Proven record in problem solving and implementation of a quality system such as MDSAP, ISO 9001, ISO 13485, FDA 21 CFR 820 , and AS9100. Experience with IATF 16949 is a plus.
- Solid experience in Internal Audits and Supplier Management, along with knowledge of receiving inspection and precision measurement tools.
- Familiarity with NADCAP or MEDACCRED requirements for Printed Circuit Board Assemblies desired.
- Strong familiarity with Design Transfer and Process Validation requirements.
- Strong background in reflow, wave soldering, all SMT processes, and the related equipment, Thru-Hole technology and process development with the ability to serve as a lead for all quality related issues. Should be familiar with IPC-610-A Acceptability of Electronic Assemblies.
- Ability to multi-task, strong time management skills, strong analytical skills, experience using statistical tools.
- Excellent verbal and written communication skills.
- Proficient use of technology including MS Office Software Package and Internet resources is expected.
- Expertise with Six Sigma/Lean/statistical tools is preferred as is Black Belt certification.
- Ability to coach and lead others in to a culture of quality and innovation.