• Job Description

  Req#: 544523

  About Us:

  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.

  *This is a Corporate Quality position within SMC Ltd. that will be seated at our Devens, MA or Somerset, WI location. This role will support both Somerset, WI and the Devens, MA locations. *

  Job Summary : We are seeking a highly skilled Serialization Quality Engineer to join our dynamic team. The ideal candidate will be responsible for ensuring the integrity and compliance of serialization processes within our medical device manufacturing operations. This role requires a strong understanding of quality assurance, regulatory requirements, and serialization technologies that are in alignment with global regulatory requirements.

  Essential Job Duties and Responsibilities:

  • Develop, implement, and maintain serialization processes to ensure compliance with regulatory standards.
  • Support the commissioning of serialization systems including FAT (Factory Acceptance Testing at Vendor), SAT (Site Acceptance Testing at manufacturing location) and validation of system including change management.
  • Conduct regular audits and inspections of serialization systems, processes and vendors.
  • Collaborate with cross-functional teams to identify and resolve serialization-related issues.
  • Monitor and analyze serialization data (push/pull) to ensure accuracy and integrity.
  • Provide training and support to staff on serialization procedures and best practices.
  • Support and help develop validation plans for standard system updates.
  • Understand and assume ownership of GS1 standards and GLN numbers and structure requirements.
  • Create comprehensive SOPs (Standard Operating Procedures) and conduct training sessions to ensure all staff are proficient in serialization practices.
  • Stay updated on industry trends and regulatory changes related to serialization
  • Prepare and present reports on serialization performance and compliance.
  • Other duties as assigned.

  Essential Qualifications:

  • Bachelor’s degree in engineering, Quality Assurance, or a related field.
  • Minimum of 3 years of experience in serialization within the medical device or pharmaceutical industry.
  • Strong knowledge of regulatory requirements including ISO 14971 and ISO 13485 and those related to serialization, including GAMP 5, Part 11, US DSCSA and EUFMD Compliance.
  • Proficiency in serialization software and technologies with hands-on experience
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills.
  • Detail-oriented with a commitment to quality and compliance.
  • Ability to travel up to 20% of the time.

  
  

  Desirable Qualifications:

  • TraceLink and Antares ATS dish experience 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 30 lbs. occasionally
  • Occasional exposure to typical machine shop physical hazards

  
  

  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.

  #IND

  #LI-JB1

• About the company

  SMC is a worldwide contract manufacturer of single use and disposable medical devices focused 100% on Medical Manufacturing. Exclusively focused on your finished device needs from concept to completion.

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