Quality Engineer at SMC Ltd.

Devens, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Jan, 26

Salary

0.0

Posted On

17 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Problem Solving, Inspection Equipment, Documentation, Continuous Improvement, Customer Communication, Process Capability, FMEA, ISO 13485, FDA Requirements, Team Collaboration, Data Analysis, Validation Plans, CAPA Management, Quality Tools, Health and Safety

Industry

Automation Machinery Manufacturing

Description

A Strategic Manufacturing Partner for Healthcare Innovators At SMC Ltd., we focus exclusively on contract manufacturing for the healthcare industry. Established in 1988 with a mission to produce high-quality products faster than anyone else, we’ve built our reputation on speed-to-market — a value that continues to drive us today. Over the years, that commitment has helped us grow into a globally recognized contract manufacturer specializing in single-use and single-patient medical, drug delivery, and diagnostic devices. Still privately owned, SMC offers our partners agility, innovation, and true strategic collaboration. Our specialized, experienced teams drive efficiency, scalability, and risk reduction at every stage of the process — ensuring that we deliver the highest quality products on time, every time. About the Opportunity As a Quality Engineer at SMC Ltd., you’ll play a key role in ensuring that every product we produce meets the highest standards of quality and compliance. You’ll collaborate with cross-functional teams, support continuous improvement initiatives, and contribute to the ongoing success of our rapidly growing organization. Job Summary: Responsible for all areas of Quality Engineering and working directly with the engineering, tooling and manufacturing functions to ensure adequate systems and inspection methods and tools are used throughout the plants for molding or assembling products. Understanding customer requirements and implementing required documentation, action plans, purchasing equipment or tools necessary to perform tasks. Ensure proper controls, operator instructions and quality tools used to verify customer’s products meet specifications at all phases within our process. Essential Job Duties and Responsibilities: * Provide Quality Engineering support for the Program Managers on customer programs as required * Review daily rejects and implement or discuss action plans * Manage and investigate customer complaints * Manage CAPAs * Disposition In-Process rejected product from previous day (MRB), if required * Make appropriate changes in documentation as required * Make appropriate changes to fixtures or inspection methods and tools * Regular attendance and professionalism. OTHER POSITION DUTIES: * Create/Maintain FMEA’s, AQPs, Deviations, Process flows, Validation Plans, IQ/OQ/PQ protocol’s, PPAP’s as appropriate * Manage, analyze, and create reports for Process Capability studies, FAIR’s, GR&Rs, and other Validation Data before sending to customer * Create, modify, and maintain History Cards/ Control Plans /Inspection Work Instructions * Make decisions regarding quality related questions as appropriate * Contact customers via verbal/written communication as appropriate * Participate in internal and supplier audits * Manage print reviews, DCNs and ECOs * Participate in design reviews as required * Visit customers and suppliers as warranted * Participate in plant/department meetings and tours as required * Work with Engineering, MFG and Tooling to develop corrective actions and continuous improvement activities. * Report any unsafe conditions to Manager or Safety committee member * Maintain cleanliness of work areas and quality measuring equipment * Observe all health and safety requirements * Other duties as assigned. Essential Qualifications: * 2-4-year college degree or Quality related experience. * Minimum of 1-3 years of experience in a Quality function * 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, ISO 13485, and FDA requirements * Ability to work well with others and independently * Excellent written, verbal, and presentation skills ADA Requirements: * Stand, walk, bend, squat, twist, reach or otherwise move frequently * Occasional repetitive motion and grasping * Occasional climbing to reach areas on machines or racks * Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently * Typically sits, grasps items or performs keyboarding for occasional operation of a computer * Exposure to typical machine shop physical hazards which may require respiratory protection 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. All applicants must be authorized to work in the US #IND #LI-JB1

Responsibilities

The Quality Engineer is responsible for ensuring that all products meet quality and compliance standards. This includes collaborating with cross-functional teams and supporting continuous improvement initiatives.