Quality Assurance Engineer

Lifecore Biomedical Inc; Chaska (MN); Híbrido; USD 85.000 - 98.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO 3 weeks

401k matching

Tuition reimbursement

Health insurance options

Descripción de la vacante

Lifecore Biomedical, Inc. in Chaska, Minnesota, seeks a Quality Assurance Engineer to lead quality activities for commercial product lines and quality system processes. You will partner with Manufacturing to investigate issues, assess risk, drive CAPA, and ensure products meet regulatory and customer expectations.

The role is hybrid with the option to work remotely up to two days per week. A BS in Engineering or Life Sciences and 3–8 years in FDA-regulated QA/quality engineering are required.

Formación

• BS in Engineering or Life Sciences required.
• 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.

Responsabilidades

• 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.

Conocimientos

Quality Assurance

Quality Engineering

Root cause analysis

CAPA

Manufacturing operations

Educación

BS in Engineering or Life Sciences

Descripción del empleo

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

4 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.