Job Description

Quality Engineer: (Medical Device Mfger)
This role is a tactical partner in the quality assurance, quality control and operations with responsibility for supporting Quality system and operations to achieve required business results. The role supports in ensuring products are manufactured safely with the highest level of quality in a timely manner that will meet or exceed customer and regulatory requirements.
Education/Certification/Licensing:

• Bachelor\xe2\x80\x99s degree in engineering or a relevant scientific discipline with minimum 3+ years of experience in manufacturing industry or a Master\xe2\x80\x99s degree in engineering or a relevant scientific discipline

Required Experience/Skills:

• Must possess excellent communication skills
• Previous experience with lean tools preferred
• Previous experience with medical device industry preferred
• Must be self-motivated and work successfully as a team

Primary Responsibilities:
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
• Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
• Analysis and review of concession requests. Review and approval of change management activities.
• Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
• Proficient in risk management practices and tools, having high expertise in process risk.
• Develop and provide input for risk management by identifying opportunities and weaknesses.
• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling.
• Support First Article Inspections. Proficiency in statistical methods and application.
• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
• Assist in the development, responsible for review & approval of process and equipment validation/qualification.
• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
• Coach and mentor others in quality topics and activities.
• Performs the job while adhering to all company policies and procedures
• Performs other related duties as necessary or assigned

Commtech