POSITION SUMMARY:

• This position is accountable for development, implementation, evaluation, and support of quality system activities for their assigned plant.
• Manage specific aspects of the quality and product safety management systems including internal audit, calibration, nonconforming material control, inspection and test, and others as assigned by the Plant Quality Manager
• Prepare appropriate quality-related reports as assigned by the Plant Quality Manager.
• Represent the company in a professional manner when interacting with suppliers, customers, and internal stakeholders.

ESSENTIAL DUTIES:

• Manage internal audit program, including development of annual audit schedules, conducting audits, and assigning auditors, evaluating, and tracking audit reports and findings, initiating and following-up on corrective actions.
• Ensures regulatory requirements like 21 CFR Part 820, MDSAP, ISO 13495, EU MDR, MDD are met.
• Participate in new product qualifications and validations to ensure quality, product safety and regulatory requirements are addressed pre-production.
• Participate in customer complaint and NCM investigations and other problem-solving efforts. Assist in measuring/collecting product and process data/information necessary to determine or validate root causes and permanent corrective actions.
• Technical lead for inspections which includes defining methods and qualifying the method (TMV, Gage R&R)
• Programming optical/vision-based measurement systems like MicroVu, Keyence etc.
• Lead process automations like paperwork reduction, Quality 4.0 initiatives, Electronic QMS implementation.
• Utilizing lean and six sigma tools to improve internal manufacturing and non-manufacturing processes.
• Defines and implements quality system processes and procedures.
• Understands all aspects of assigned production line(s) to help minimize scrap and complaints.
• Implements corrective actions and uses CAPA system to consistently improve product quality.
• Prepares written protocols and reports.
• Performs a variety of complex tasks using experience and judgment.
• Mentor junior level team members.
• May lead and direct the work of others in various projects and assignments.
• Upholds Spectrum Plastics vision and core values.
• Performs other duties as required.

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

Required:

• Bachelor's degree or higher in Engineering (Mechanical/Industrial/Engineering Management/Biomedical/Electrical)
• 7 years of industry experience in a similar role
• Has knowledge of commonly used concepts, practices, and procedures within the field, including regulatory affairs.
• Ability to problem solve, identify errors and deficiencies and perform research independently
• Ability to apply knowledge to their job function using pre-established guidelines and instructions
• Accuracy, attention to detail, and thoroughness
• Proficient in computer skills and ability to use MS office, Minitab etc.
• Proficient communications skills
• A wide degree of creativity and latitude
• Ability to comprehend and comply with company safety and quality standards
• Ability to follow oral and written instructions

Preferred:

• Previous experience in Quality Assurance
• Rudimentary knowledge of statistics
• Medical device experience
• Certified Quality Engineer (CQE)
• Lean Six Sigma Green Belt or Black Belt

WORKING CONDITIONS:

This position requires about 50% of time spent sitting and working on computer. The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.

NOTE: This job description is not intended to be an exhaustive list of all possible duties, responsibilities and or qualifications. Other duties, responsibilities and/or qualifications may be assigned to this position.