Sr. Quality Engineer (process mfg exp in regulated industry req)

Sr. Quality Engineer (process mfg exp in regulated industry req) #twiceasnice Recruiting - 4.4 Hollywood, FL Job Details Full-time $120,000 - $140,000 a year 1 day ago Benefits Health savings account Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Quality control corrective actions Teamwork Regulatory compliance Corrective and preventive actions (CAPA) Assembly Bachelor's degree in engineering Bachelor's degree FMEA Root cause analysis Manufacturing company experience

Full Job Description Senior Quality Engineer Location:

Greater Miami Area, FL (near Amelia Earhart Park)

Salary:

$120,000-$140,000+ (Negotiable, DOE) +

Company-Based Annual Bonus Excellent Benefits:

Medical (100% paid premiums for employees, 80% for family), Dental, Vision, 401k,

Life, Disability, HSA, Vacation, Holidays, Sick Time Job Type:

Full-Time; Monday-Friday Sponsorship is not available Senior Quality Engineer (manufacturing exp. req.) Description Our client is seeking a Sr. Quality Engineer to join their team in the Miami area. They are a small, highly capable group that manufactures their own medical devices while also supporting full product design and development. This is a hands-on role centered around quality events and manufacturing process improvement within a collaborative team. You will lead investigations, develop manufacturing and inspection procedures, and play a key role in ensuring consistent, high-quality production. You will spend about 50% of your time supporting quality initiatives, 40% on manufacturing processes, and 10% supporting product development activities. You will also act as a bridge between the Quality team (4) and Manufacturing team (5), supporting cross-functional collaboration and contributing to continuous improvement efforts If you enjoy variety in your day and working across functions rather than staying in a narrowly defined role, this could be a great fit. This opportunity offers the chance to make a meaningful impact and have greater influence within a smaller, agile team. In this environment, your ideas will be heard and put into action, something that can be harder to find in larger organizations. They also offer strong benefits for a company of this size, including 100% employer-paid premiums for employees and 80% for dependents. Senior Quality Engineer (manufacturing exp. req.) Responsibilities Design, develop, and enhance manufacturing processes Develop inspection methods, lead CAPA and root cause analysis, and ensure compliance Review engineering drawings for tolerancing, manufacturability, and inspection feasibility Conduct tolerance stack-up analysis and risk assessments and author FMEAs Develop work instructions, assembly procedures, and maintain BOMs Troubleshoot production issues and implement corrective actions and lead

IQ/OQ/PQ

Design and implement tooling, fixtures, and test equipment for production and validation Lead continuous improvement initiatives to improve yield, reduce scrap, and increase efficiency Support product development while ensuring compliance with design control requirements Develop and execute design verification and validation protocols Support audits, manage documentation, and design CAD models and tooling in SolidWorks Senior Quality Engineer (manufacturing exp. req.) Qualifications Bachelor's degree in engineering Experience working within a highly regulated environment Strong experience leading investigations, including CAPA, NCRs, and root cause analysis Experience developing manufacturing and inspection procedures Exposure to validation activities (IQ/OQ/PQ), including equipment or process validation Able to work onsite each day required About #twiceasnice Recruiting Across industries, roles, and North America, we help clients quickly attract top talent with custom-built searches. With the lowest fee in the industry, the longest guarantee, and commission-free senior recruiters - we align our interests with the long-term success of every placement. Need recruiting help? www.twonice.com

Job Type:

Full-time Pay:

$120,000.00 - $140,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Health savings account Life insurance Vision insurance Application Question(s): What types of regulated environments have you worked in, and which regulatory standards or agencies are you familiar with? (e.g., FDA, ISO 13485, etc.) Can you describe any design experience you have related to manufacturing, particularly tooling, fixtures, or jigs? (not required) Our client has budgeted this role for $120,000-$140,000 + Annual Bonus Potential. They are open to being more competitive for the right candidate. Does that fall within your salary expectations or what are you seeking to make a move? This role is 100% onsite and our client is in the Miami area, just a few minutes from Amelia Earhart Park. Are you able and willing to work onsite each day? If so, how long is your commute? If you have a LinkedIn profile, please share the URL.

Education:

Bachelor's (Required)

Experience:

engineering : 5 years (Required) developing quality inspection or test methods : 3 years (Required) supporting quality within highly regulated environments : 3 years (Required)

CAPA :

3 years (Required) nonconformance reporting (NCRs) : 3 years (Required) leading investigations related to CAPA, NCRs, or complaints : 2 years (Required)

Work Location:

In person