Quality Engineer II (Medical Device/ ISO 13485/ CFR Part 820)

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.

Job Summary:

Responsible for all areas of Quality Engineering on customer programs. Responsible for working directly with the program management, tooling and manufacturing functions to ensure adequate systems, documentation, inspection methods and tools are used throughout the organization for molding and assembling healthcare products. Understanding customer requirements and implementing appropriate controls, documentation, action plans, and tools necessary to perform quality related tasks at all phases within the process.

Essential Job Duties and Responsibilities:

• Create and maintain pFMEA's, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.
• Analyze FAIRs, process and test method validation data before sending to the customer.
• Lead customer complaint and CAPA investigations as required.
• Manage ECOs, deviations, and documentation updates as required.
• Generate and maintain applicable quality system documentation as needed.
• Manages activities for handling healthcare products from receiving to shipping.
• Assessing and ensuring compliance through training, auditing, and corrective and preventive actions.
• Participate in customer audits and provide input to any observations.
• Train personnel as required
• Review and discuss daily rejects and implement action plans
• Make appropriate changes to prevent recurrence of quality related issues.
• Make appropriate changes to fixtures or inspection methods and tools as required.
• Regular attendance and professionalism.
• Make decisions regarding quality related questions as appropriate
• Contact customers via verbal/written communication as appropriate
• Participate in design reviews as required
• Visit customers and suppliers as required
• Participate in plant/department meetings and tours as required
• Work with Engineering, Manufacturing and Tooling on continuous improvement activities
• Maintain cleanliness of work areas and quality measuring equipment
• Observe all health and safety requirements and report any unsafe conditions
• Other duties as assigned

Essential Qualifications:

• Bachelor of Science Degree
• 5-7 years of experience as a Quality Engineering in the healthcare industry
• Must have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation
• Must be able to read and understand 2D detailed part/article drawings
• Must understand the use all quality related inspection equipment
• Must have excellent problem solving and mistake proofing skills
• Must have computer skills and familiarity with Word and Excel programs
• Must have knowledge of SPC
• Effective interpersonal and problem-solving skills
• Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization

• Excellent written, verbal, and presentation skills

ADA Requirements:

• Typically sits, grasps items and performs keyboarding for frequent operation of a computer
• Stand, walk, bend, reach or otherwise move about regularly
• Lift, move, or otherwise transfer items up to 40 lbs. occasionally, >20 lbs. frequently
• Occasional exposure to typical machine shop physical hazards
• Travel by air or car frequently

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.

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