A manufacturing company is seeking a Quality Engineer to join their team near Etters, PA. This position is responsible for overseeing the different advertising projects, activities, and channels that the organization uses to reach customers. A bachelor’s degree in engineering or a related field and 2+ years of experience with medical devices is required. This is a full-time position with excellent benefits and 401k.

QUALITY ENGINEER SKILLS

-Bachelors degree in a Life Science or related field
-Must have knowledge and expertise in FDA 21 CFR 820, ISO 13485, ISO 14971, cGMP
-Must have 2+ years with medical devices, quality or manufacturing
-CQE or CQT is a plus but not required

*If interested, please apply with your most updated resume including your minimum salary requirement and why you left/or are looking to leave your current company. *

Activ8 Recruitment & Solutions / Renaissance Resources Inc. has been a trusted leader in North American recruiting for Japanese businesses for over 25 years. We specialize in connecting top talent with companies in the Automotive, Electronics, Food & Beverage, Logistics, Manufacturing, Oil & Gas, Banking & Finance, and Entertainment industries. Our client-focused approach ensures that we understand your unique needs, whether you’re a company seeking skilled professionals or a candidate looking for the right career opportunity. By working closely with each individual, we provide tailored solutions that drive success.
We screen ALL Candidates to verify the validity of each applicant’s provided information. Upon submitting your resume, we will contact only those candidates that we deem qualified for our client. If we do not contact you, we do not see the fit for the position. If we are unable to reach you in a reasonable timeframe, you will be eliminated from the pool of potential candidates.
We prioritize direct applicants; third-party resumes may not be reviewed.
Job Type: Full-time
Pay: $75,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Application Question(s):

• Do you have knowledge and expertise in FDA 21 CFR 820, ISO 13485, ISO 14971, cGMP?
• Do you have a CQE or CQT?

Education:

• Bachelor’s (Required)

Experience:

• medical device: 2 years (Required)

Ability to Commute:

• Etters, PA 17319 (Required)

Ability to Relocate:

• Etters, PA 17319: Relocate before starting work (Required)

Work Location: In perso

-Utilize key Quality Engineering (QE) principles, tools, and practices to develop and optimize process controls and quality system processes that are aligned with the overall business goals
-Partner with manufacturing to implement process improvements and address quality events including non-conformance, product disposition, root cause investigation, CAPA and failure investigation.
-Collaborate with Quality Laboratory and manufacturing to implement process improvements.
-Lead project and investigation teams.
-Lead customer complaint investigations.
-Partner with manufacturing to assist in validation efforts and change controls.-Collaborate in reviewing and editing quality documents.
-Assist in supplier evaluation and qualification activities.
-Maintain compliance with all company policies and procedures.