JT011 - MANUFACTURING ENGINEER II

Villalba, Puerto Rico

Temporary

Medical Device

Mid Level

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation
Computer System Validation (CSV)
Manufacturing, Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Devices
Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.
Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes).
These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

Qualifications:

Bachelor’s degree in Engineering
3+ years of relevant experience.
Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
Process Validation, Equipment IQ and Computer software validation knowledge
Technical writing knowledge and Communication skills
Investigation and root cause analysis skills
Must have knowledge in Process Validation, Equipment IQ and Computer software validation.
Provides technical and sustaining engineering support in a manufacturing area; therefore, investigation and root cause analysis skills are required to solve problems or improve effectiveness of job area (inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality).Good writing skills and communication skills in English and Spanish to have successful and productive meetings within a cross functional team
Experiences with manufacturing processes creation / improvements
Experience with process validations (IQ, PD, OQ, PQ)
Special build coordination and follow up in manufacture.
Shift: 1st shift and 2nd shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Apply for this position

Required*

First Name*

Last Name*

Email Address*

Phone*

Address

Resume*

We've received your resume. Click here to update it.

Attach resume or Paste resume

Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

Do you possess a Bachelor's degree in Engineering?*

Do you have experience in Process Validation, Equipment IQ or Computer software validation?*

Do you have experience implementing corrective and preventive actions? (e.g. CAPAs)*

The following questions are entirely optional.

Invitation for Job Applicants to Self-Identify as a U.S. Veteran

A “disabled veteran” is one of the following:
- a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
- a person who was discharged or released from active duty because of a service-connected disability.
A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran status

I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE
I AM NOT A PROTECTED VETERAN
I DON’T WISH TO ANSWER

Voluntary Self-Identification of Disability

Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 05/31/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Please check one of the boxes below:

YES, I HAVE A DISABILITY, OR HAVE HAD ONE IN THE PAST NO, I DO NOT HAVE A DISABILITY AND HAVE NOT HAD ONE IN THE PAST I DO NOT WANT TO ANSWER

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Name	Date

Human Check*

Submit Application