Quality Engineer

SMC Ltd; Harvard (MA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Paid holidays

PTO

Tuition reimbursement

Training programs

Career growth

Life insurance

Disability insurance

Employee assistance

Promotional opportunities

Job summary

SMC Ltd. is seeking a seasoned Quality Engineer to oversee quality activities across healthcare programs, collaborating with program management, tooling and manufacturing.

The role focuses on implementing robust quality controls, documentation, and tools for molding and assembling healthcare products. Ideal candidates will have 5–10 years in healthcare quality, strong leadership, and experience with ISO 13485 and 21 CFR Part 820, plus NPDI involvement and a proven track record in problem solving

Qualifications

• Bachelor of Science Degree.
• 5-10 years of quality engineering experience in healthcare.
• Experience with ISO 13485 and 21 CFR Part 820.
• Ability to read and understand 2D drawings.
• Familiarity with quality inspection equipment and SPC.

Responsibilities

• Create and maintain pFMEA, Control Plans, PPAPs and validation plans.
• Lead CAPA investigations and customer complaints.
• Manage ECOs, deviations and documentation updates.
• Oversee quality systems documentation and audits.
• Ensure compliance through training and corrective actions.
• Participate in design reviews and supplier visits.

Skills

Problem solving

Interpersonal skills

Leadership

Reading 2D drawings

Quality systems

Education

Bachelor of Science

Tools

SPC

Job description

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 complaints and CAPA investigations as required.
• Manage ECOs, deviations, and documentation updates as required.
• Generate and maintain applicable quality system documentation as needed.
• Manage 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.
• Maintain regular attendance and professionalism.

Other Position Duties

• 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.
• 5-10 years of experience as a Quality Engineer in the healthcare industry, with New Product Development or New Product Introduction experience required.
• 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 of 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.
• New product development experience - minimum of 2 years' experience.
• Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization.

Nice to Have

• Experience with validating large-scale automation.
• Experience with 21 CFR Part 4 Combination Products.

ADA Requirements

• Bend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periods.
• Lift, move or otherwise transfer up to 50 lbs. frequently, or more occasionally.
• Walk, stand or otherwise move about continuously.
• Exposure to machine shop physical hazards including chemicals which may require respiratory protection.
• Typically sits, grasps items and performs keyboarding for occasional operation of a computer.

Benefits

• Clean, Climate-Controlled Environment.
• Stable schedule.
• Paid holiday and PTO.
• Health, dental, and vision insurance.
• 401(k) retirement savings.
• Life and disability insurance.
• Promotional opportunities.
• Training and career growth programs.
• Amazing co-workers.
• Tuition reimbursement.
• Employee Assistance Program.

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.

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 accommodation 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.