SMC Ltd · 4 days ago
Quality Engineer II
Devens, MA
Full-time
Onsite
Senior Level
$65K/yr - $110K/yr
5+ years expSMC Ltd. is a globally recognized contract manufacturer specializing in healthcare products. As a Quality Engineer II, you will ensure that products meet quality and compliance standards while collaborating with cross-functional teams and supporting continuous improvement initiatives.
ManufacturingMedical Device
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
Qualification
Required
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
Company
SMC Ltd
SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries.
501-1000 employees
H1B Sponsorship
SMC Ltd has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Carlos Castro
Talent Acquisition Partner
Jeff Burke
Human Resource Partner
Company data provided by crunchbase