Quality Assurance Manager

Quality Assurance Manager

PLITEK is seeking a proactive and experienced 
Quality Assurance Manager
 to lead our quality initiatives and ensure consistent compliance with our Quality Management System (QMS). This role is responsible for developing and implementing product and system-level control plans, supporting new product introductions (NPI), and driving continuous improvement across all quality-related functions. This is an on-site position.

The ideal candidate will have a strong understanding of quality engineering tools, regulatory standards (ISO 9001:2015 and 13485:2016), and will work collaboratively across departments (engineering, production, purchasing, and sales) to maintain high-quality standards. This position also involves direct interaction with customers and suppliers to resolve quality concerns and drive performance improvement.

Key Responsibilities Include:

• Hire, train, and manage quality personnel; resolve internal quality issues and lead cross-functional and strategic quality initiatives.
• Interpret customer requirements and integrate them into internal processes; lead process capability studies, control plans, FMEAs, and process mapping.
• Oversee and support PPAP, APQP, R&R studies, and NPI efforts; ensure product and process compliance through data analysis and ongoing monitoring.
• Lead internal, customer, and supplier CAPAs; perform root cause analysis, communicate results, and verify corrective action effectiveness.
• Represent QA in project planning and kick-offs; develop inspection and quality plans; facilitate PFMEA, DFM/DFA, and APQP processes.
• Maintain and improve ISO 9001:2015 and ISO 13485:2016 certification; lead internal audits, prepare for external audits, and drive continual improvement initiatives.
• Train manufacturing staff on quality standards; lead scrap and rework reduction efforts; participate in engineering change control processes.

Required Skills & Qualifications:

• Proven experience in a quality assurance or quality engineering leadership role.
• Strong knowledge of ISO 9001, ISO 13485, APQP, PPAP, FMEA, control plans, and statistical tools (SPC, R&R).
• Ability to read and interpret engineering drawings, specifications, and quality standards.
• Effective leadership, team building, and communication skills.
• Proficiency with quality management software, Microsoft Office, and data analysis tools.
• Strong analytical and problem-solving skills.
• 5 years of experience or equivalent.

What We Offer:

• Top-Tier Career Opportunity
   – Exposure to multiple aspects of Quality Assurance role
• Comprehensive Benefits
   – Medical, dental, life, and short-term disability insurance
• 401(k) with Company Match
   – Invest confidently in your future
• Paid Time Off
   – A healthy work-life balance is part of our culture
• Inclusive, Team-Oriented Culture
   – Collaboration and innovation are at our core
• Holiday Paid

PLITEK is a leading U.S. based precision die cutting and custom converting manufacturer, specializing in converting solutions for medical devices, automotive components, aerospace materials, electronics, and packaging. PLITEK delivers scalable, ISO-certified manufacturing solutions with a focus on quality, speed to market, and sustainability.

PLITEK 's die cutting and converting capabilities include precision die cutting, multi-layer laminating, custom film extrusion, specialty adhesive coating, release liner coating, surface treatment, slitting & rewinding, printing, and packaging.

Our value-added services also include material selection assistance, design support, rapid prototyping, clean room manufacturing, and contract assembly & packaging.

We focus on providing solutions for our customers and strongly value quality, innovation, hard work, and good business ethics.

Mission: World-Class Excellence

We maximize client satisfaction and employee pride of ownership by demonstrating competence and creativity with professionalism. We are committed to quality by using best practice manufacturing processes and state-of-the art technology to deliver world-class products and services.

Our Core Values

– Integrity

– Strict Confidentiality

– Strong Relationships

– Entrepreneurial Spirit

– Partnership- Supporting Our People and Community

PLITEK is an Equal Employment Opportunity employer and proud to have created a collaborative culture where employees around the world are seen, heard, and respected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, or marital status or status as a protected veteran, or any other legally protected classification.

Pay: $90K to $126K per year