We are seeking a Quality Engineer with strong experience in the medical device and injection molding industry to support process improvement, compliance, and product quality initiatives. The ideal candidate will bring a solid technical background, strong documentation skills, and proven knowledge of ISO 13485:2016 and ISO 9001 quality systems. This position requires someone who can thrive in a fast-paced environment, work cross-functionally, and drive corrective actions to completion.

QUALIFICATIONS:

• Bachelor’s degree in Engineering or related field preferred.
• 3–5+ years of quality engineering experience in the medical device or injection molding industry.
• Strong knowledge of ISO 13485:2016 and ISO 9001 controlled quality processes.
• Experience with QMS documentation, PPAP, FAI, ECO processes, and manufacturing quality forms.
• Familiarity with GD&T and standard drafting practices.
• Effective communication skills to work cross-functionally and resolve quality issues.
• Self-starter with strong organizational, leadership, and project management abilities.
• Detail-oriented with proven ability to manage quality data and maintain compliance documentation.
  Design Hire is proud to be an Equal Employment Opportunity / Affirmative Action employer. It is our policy to consider for employment all individuals regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, gender, sex, sexual orientation, gender identity and/or expression, genetic information, veteran status, or any other characteristic protected by federal, state or local law.
  Employment Eligibility: If hired, a Form I-9 Employment Eligibility Verification must be completed at the start of employment. Temporary work authorization or the need for sponsorship may disqualify you from employment.
  Job Type: Full-time
  Pay: $60,000.00 - $85,000.00 per year

Education:

• Bachelor’s (Preferred)

Experience:

• Plastics injection molding: 1 year (Preferred)
• medical Device: 1 year (Preferred)
• ISO 9001: 1 year (Preferred)
• Quality control: 1 year (Preferred)
• Quality assurance: 1 year (Preferred)

Ability to Commute:

• Erie, PA (Preferred)

Work Location: In perso

• Support quality assurance in production and cleanroom environments, ensuring adherence to quality standards and regulatory requirements.
• Improve product quality and process manufacturing by applying technical expertise and problem-solving methodologies.
• Create and maintain quality forms and documentation such as Quality Inspection Plans (QIP), quality alerts, work instructions, and other QMS documents.
• Review and number part prints, maintain a part print database, and update records for quality tracking.
• Perform and document First Article Inspections (FAI), dimensional studies, and statistical analyses such as GR&R and Capability Studies.
• Coordinate and prepare Production Part Approval Process (PPAP) reports and submissions for customers.
• Participate in the Engineering Change Order (ECO) process, updating ISO documentation and supporting quality system compliance.
• Generate historical data charts and reports for quality evaluations and continuous improvement initiatives.
• Support and lead quality investigations, root cause analyses, and corrective/preventive action projects across departments.