Supervisor, Pharma Quality Engineering

About SMC Ltd:

SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

Job Summary: Responsible for leading and mentoring the Quality Engineering and Technician team members while ensuring quality assurance and control processes for pharmaceutical device development and manufacturing are compliant with regulatory standards, including FDA, cGMP, and ISO 13485.

Essential Job Duties and Responsibilities:

• Supervise with direct reporting responsibilities, mentor, train, and assigning priorities for Quality Engineering team to ensure consistent performance and professional development to meet SMC and Customer expectations.
• Provides technical and administrative support and guidance to direct and indirect reports for validation planning, execution, results, and throughput. 
• Develop, enhance, and implements systems, procedures, and strategies to establish or improve overall quality standards, standard repairs, process controls, and inspection methods to be compliant to ISO 13485, cGMP, and FDA systems and procedures.
• Collaborates with customers and other stakeholders to identify and resolve problems with delivered products. 
• Collaborates with Production Quality to develop and execute to improvements to ensure quality integration throughout the product lifecycle to satisfy external and internal quality goals and objectives.
• Oversees Corrective/Preventative Action activities to include addressing customer complaints for product quality.
• Verifies quality system activities and records for product validation and change compliance are accurate and complete.
• Solicits feedback from internal and external customers; Develops and implements improvements.
• Recommends new technology to improve quality, service, and decrease cost.
• Performs other duties as assigned. 

Essential Qualifications:

• B.S. in Engineering with an emphasis on Quality Assurance OR six years of related Quality experience.  
• Minimum 5-7 years of quality engineering experience in pharmaceutical, medical device, or combination product manufacturing, with at least 2 years supervisory experience.
• Working knowledge of cGMP, ISO 13485, FDA requirements, and other applicable regulation encompassed with the ability and skill to represent SMC in regulatory audits. 
• Strong supervisory and leadership skills.
• Solid understanding and application of GD&T and basic blueprint interpretation skills.
• Strong customer relations, customer audits and statistical skills.
• Demonstrated effective verbal and written communication skills.
• Excellent organizational skills and attention to detail. 
• Excellent time management skills with a proven ability to meet deadlines. 
• Strong analytical and problem-solving skills.
• Proficient PC skills in a Windows environment.

Desirable Qualifications:

• MS in a related field is preferred.
• Experience in the pharmaceutical industry preferred.

ADA Requirements:

• Typically sits, grasps items and performs keyboarding for frequent operation of a computer
• Stand, walk, bend, reach or otherwise move about occasionally
• Lift, move or otherwise transfer items up to 50 lbs. occasionally
• Exposure to typical machine shop physical hazards which may require respiratory protection

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job.  If your experience is close to what you see listed here, please still consider applying.  We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.  Please let us know if you require reasonable accommodations during the interview process. 

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

 Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

#LI-HN1

#IND