Quality Assurance Engineer

Lifecore Biomedical; Chaska (MN); Hybrid; USD 85,000 - 98,000; Full time

Benefits offered by this job

Medical insurance plans (HSA)

Dental insurance

Vision insurance

Disability insurance

Life insurance

PTO 3 weeks

Company holidays

Personal holidays

Family leave

Tuition reimbursement

401k with company match

Job summary

Lifecore Biomedical in Chaska, MN is seeking a Quality Assurance Engineer to lead quality engineering for medical device/pharma product lines and quality system processes. You will partner with Manufacturing to investigate issues, assess risk, and drive improvements.

The role supports a hybrid work model with remote options up to two days per week. Candidates should have a strong QA background in FDA-regulated environments and a BS in Engineering or Life Sciences.

Qualifications

• Experience leading quality engineering activities in medical device/pharma settings.
• Strong background in CAPA, RCA, and quality systems.
• Experience supporting manufacturing operations in FDA-regulated environments.

Responsibilities

• Lead root cause investigations for nonconforming product and CAPA.
• Provide quality engineering support for assigned product lines and processes.
• Establish and monitor quality trends and process capability data.
• Collaborate in risk analysis (FMEA) for product/process/quality system changes.
• Review and approve quality records, procedures, and release products.

Skills

Quality engineering

CAPA

Root cause analysis

Manufacturing support

FDA regulated environment

Education

BS in Engineering or Life Sciences

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Assurance Engineer

Regular Full-Time Professionals Chaska, MN, US

2 days ago Requisition ID: 1592

It's not what we make. It's what we make possibleand the possibilities at Lifecore are endless!

This full-time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities.

Lifecore is seeking aQuality AssuranceEngineer to lead quality engineering activities for assigned commercial medical device or pharmaceutical product lines and/or quality system processes. This role ensures finished products consistently meet quality standards, regulatory requirements, and customer expectations.

You will serve as a key quality partner to Manufacturing, using quality engineering tools to investigate issues, assess risk, and drive continuous improvement across processes, equipment, and quality systems.

This is a hybrid position, with the option to work remotely up to two days per week.

In this critical role, you will:

• Lead, support, and approve root cause investigations for nonconforming product, including corrective and preventive actions (CAPA)


• Provide quality engineering support for assigned product lines and/or critical processes


• Establish, analyze and monitor quality trends and process capability data


• Collaborate with cross-functional teams to participate in or facilitate risk analysis (e.g. FMEA) for product, process, or quality system changes


• Review and approve quality records, procedures, and technical documentation; release product to customers

This position could be a great fit for you if you have a passion for problem solving, and the following:

• BS in Engineering or Life Sciences


• 3 - 8 years of Quality Assurance or Quality Engineering experience in an FDA regulated industry


• Strong understanding of root cause analysis, CAPA, and quality systems


• Experience supporting manufacturing operations


• Background in biology and/or chemistry production processes a strong plus!

Starting Salary: $85,000 - $98,000 annually with consideration for relevant experience

Lifecore offers a highly competitive total rewards package, including:

• Opportunities to learn and grow with a well-respected company


• Competitive compensation with annual reviews and a company-wide incentive bonus


• Benefits that start the first of the month after you join Lifecore as a full-time employee:
  
  
  • 3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution.
  
  
  • Low cost dental and vision insurance
  
  
  • Short term disability, long term disability and life insurance all 100% company paid
  
  
  • 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!)
  
  
  • 9 paid company holidays plus 2 personal holidays
  
  
  • Family leave
  
  
  • Tuition reimbursement
  
  
  • 401k plan with company matching contribution
  
  

Meet Lifecore Biomedical, LLC:

Lifecore Biomedical, Inc. (Nasdaq: LFCR ) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories.