Orbis Clinical is seeking a Quality Engineer II located in Marlborough, MA for 6 months.

Job Title: Quality Engineer II

Location: Marlborough, MA

Contract: 6 months

Essential Duties and Responsibilities:

We are seeking an experienced Quality Engineer II that will actively participate in the Company Quality Management System. This role is responsible for providing Quality Engineering support for new product development, manufacturing transfer activities and supporting manufacturing for commercial products.

Responsibilities:

• Must be familiar with Validation Principles and Concepts, Design Controls Processes in accordance with regulatory requirements (e.g., Quality ISO standards, ASME BPE, CE, BPOG, REACH, etc.).
• Supports the New Product Introduction (NPI) team with deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. Work with multi-functional product development teams to help verify new product development deliverables and compile product Design History Files to support product release.
• Experience in areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. Product line support will focus on hardware devices and associated consumables used for biotech products.
• Supports the comprehensive completion of risk management (FMEA), Design and Process Verification activities for products and processes.
• Assists in the development and validation of appropriate test methods for product and process performance.
• Review of Equipment IOPQ’s in support of commercial operations.
• Strong organization skills with the ability to effectively muti-talk and prioritize
• Self-motivated with sound judgment and problem-solving skills.
• Assists with customer complaint investigations when required
• Effective in executing change controls and running change control review board meetings.
• Review and approval of nonconformances, deviations, failure investigations and corrective action plans prior to implementation when required.
• Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results

Qualifications/Skills:

• BA/BS degree (in a Biological Science, Engineering, or Physical Science required).
• Must have prior experience in New Product Development Quality Engineering.
• Experience with biotech hardware and consumable products and associated manufacturing processes.
• Basic understanding of cell culture and filtration and chromatography operations in a bioprocess setting is required for this position.
• Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred.
• Minimum of 3-5 years’ experience as a Quality Engineer in an ISO 9001 Quality Management System or equivalent.
• Internal Auditing.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $45.16 - $55.17 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.