Quality Engineer Process Validations

Position Summary

The QC Process Engineer shall be responsible for evaluating and providing oversight for the quality function to all process validations and qualifications for the company. The Quality Engineer – Validations will be responsible for comprehensive management of all activities required to successfully support the execution of process validations and qualifications maintaining full compliance to medical device and biologic / pharmacological regulations.

Essential Duties & Responsibilities

• All activities required to support process validations and qualifications.
• Accountable for evaluating process validations and qualifications using a risk-based approach, for all activities related to the GMP / Quality System. This minimally includes the following:

• Tracking and updating the progress of process validations and qualifications in the Master Validation Plans
• Reviewing and approving process validations and qualifications
• Performing periodic reviews of process validations and qualifications

• Review all applicable procedures (SOPs, WI, and Forms) to ensure that they comply within the scope of what was validated.
• Facilitate meetings with management (e.g. QA, Technical Operations and R&D) when validations/qualification results are failing and / or timelines are missed putting the company’s objectives at risk.
• Facilitate cross-functional groups to assure participation / input into equipment qualifications.

Position Expertise/Qualifications

• Bachelors of Science in Biology, Biochemistry, Chemistry, Engineering or other technical discipline is required.
• Certified Quality Engineer (CQE)
• Minimum Years of Experience GMP operations and / or quality operations
• 3 years of Process validation / qualifications
• 2 years of Process validation / qualifications

Skills & Abilities

• Thorough proficiency in ISO 13485 and 14971, 21 CFR 210, 211, 820, 803, 806, 1270, and 1271.
• Identify and solve technical problems.
• Collaborate with peers to resolve problems that cross into inter-related units.
• Communicate effectively (e.g. explain difficult concepts with the intent of persuading others to adopt point of view).
• Organize effectively.
• Follow detailed instructions yet operate and think independently.
• Keen observational and troubleshooting skills; critical thinking; “think outside the box” skills.
• Lead cross-functional groups for the execution of risk management activities.
• Work effectively on multiple projects.
• Fluent (oral/written) English.
• Computer Proficiency – Word and Excel.

Travel Requirements

• Up to 10% Domestic.

Essential Physical Requirements

• Standing and walking more than three-fourths of the workday.
• Sitting, more than three-fourths of the workday.
• Hearing, more than three-fourths of the workday.
• Vision, more than three-fourths of the workday.
• Communication – verbal, up to one-tenth of the workday.
• Ability to lift up to 10 lbs: up to one-tenth of the workday.

Featured benefits

At TissueTech Inc., we offer competitive total rewards compensation. Our commitment to our employees includes benefit programs that are comprehensive, diverse, and designed to meet the various needs across our associate population. We take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions.

Our inclusive benefits include, but are not limited to:

• Paid Time Off including vacation, floating holiday and paid bereavement.
• Comprehensive health, vision, dental, HSA match, FSA and dependent care, STD, LTD, Life & AD&D Insurance, Supplemental insurance.
• Prepaid Legal plan.
• Pet Insurance.
• 401k match - an investment in your future.
• Exclusive employee discounts.
• Company-wide events and outings.

#LI-RM1

COVID-19 Vaccination Requirement

TissueTech, Inc. requires its employees to be fully vaccinated against COVID-19 where allowable under the law, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents them from being vaccinated. If you are vaccinated, you are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status.

ADA Statement

Candidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the essential functions of the position with a reasonable accommodation.