What are the responsibilities and job description for the Lead Quality Engineer position at PeelMaster Packaging Corporation, A Spectrum Plastics Group Company?
JOB SUMMARY: This hybrid role is responsible for both executing quality
engineering activities and supervising the Quality Control (QC)
inspection team. The position ensures that products meet internal
specifications, customer requirements, and regulatory standards through
robust inspection, process control, and quality system oversight. The
individual will lead problem-solving efforts, manage QC operations, and
support continuous improvement initiatives across manufacturing. QUALITY
ENGINEERING DUTIES: - Participate in validations (IQ/OQ/PQ) and process
qualifications - Analyze quality data and generate reports on trends and
improvements - Execute Gage R&R/test method validation - Perform risk
analysis (FMEA) and process capability studies - Develop and maintain
control plans and inspection plans - Lead root cause investigations and
corrective/preventive actions (CAPA) - Lead and maintain change control
efforts - Conduct layered process audits and support internal/external
audits QUALITY CONTROL SUPERVISION: - Supervise day-to-day QC inspection
activities across shifts - Provide training, coaching, and schedule for
QC inspectors - Ensure proper use of measuring equipment and adherence
to Good Documentation Practices (GDP) - Ensure timely review and
disposition of nonconforming product - Drive compliance with procedures
and standard work at the inspection level - Maintain equipment
calibration compliance (including scheduling and quoting) - Perform
employee annual reviews and individual management - Develop and maintain
Quality Lab metrics / KPIs - Perform other duties as assigned
EXPERIENCE, SKILLS, EDUCATION AND TRAINING: QUALIFICATIONS
(Education/Experience/Knowledge, Skills & Abilities) - Bachelor\'s
Degree or equivalent, or 3-5 years\' related experience and/or training,
or equivalent combination of education and experience in quality
engineering in the medical industry - Knowledge of regulatory
requirements and industry standards (e.g., FDA QSR, ISO 13485). - Strong
understanding of quality management systems, material inspection
techniques, and root cause analysis methodologies. - Knowledge of GD&T
print interpretation, CAD Models, Statistical technique and Software,
Programming CMM\'s, Validation Activities (IQ, OQ, PQ), Cleanroom
practices, Sampling Technique. - Proficiency in data analysis and
problem-solving tools (e.g., 8D, FMEA, Pareto analysis). - Experience
leading or participating in CAPA investigations and resolution
activities. - Proficiency in problem-solving tools and techniques (e.g.,
5 Whys, Fishbone diagram, DMAIC). - Above average math skills (sound
knowledge in both statistics and calculus) - Ability to work with a high
volume of documents in a fast-paced environment - Experience with
programming and operation of Coordinate Measuring Machines (CMM),
inspection of machine components, and performance of gage R&R studies
preferred - Strong written, verbal, time management and interpersonal
skills - Ability to communicate effectively with all levels of staff and
management, both internal and external - Collaborate with
cross-functional teams - Leadership skills and team player - Highly
organized - Must have a strong attention to details - Strong Computer
skills; Microsoft Office (Word, Excel) and Minitab - Must be able to
lift up to 25 lbs. - Must be able to sit or stand for long periods of
time - Must be able to climb up and down stairs - Travel is required to
support company initiatives
engineering activities and supervising the Quality Control (QC)
inspection team. The position ensures that products meet internal
specifications, customer requirements, and regulatory standards through
robust inspection, process control, and quality system oversight. The
individual will lead problem-solving efforts, manage QC operations, and
support continuous improvement initiatives across manufacturing. QUALITY
ENGINEERING DUTIES: - Participate in validations (IQ/OQ/PQ) and process
qualifications - Analyze quality data and generate reports on trends and
improvements - Execute Gage R&R/test method validation - Perform risk
analysis (FMEA) and process capability studies - Develop and maintain
control plans and inspection plans - Lead root cause investigations and
corrective/preventive actions (CAPA) - Lead and maintain change control
efforts - Conduct layered process audits and support internal/external
audits QUALITY CONTROL SUPERVISION: - Supervise day-to-day QC inspection
activities across shifts - Provide training, coaching, and schedule for
QC inspectors - Ensure proper use of measuring equipment and adherence
to Good Documentation Practices (GDP) - Ensure timely review and
disposition of nonconforming product - Drive compliance with procedures
and standard work at the inspection level - Maintain equipment
calibration compliance (including scheduling and quoting) - Perform
employee annual reviews and individual management - Develop and maintain
Quality Lab metrics / KPIs - Perform other duties as assigned
EXPERIENCE, SKILLS, EDUCATION AND TRAINING: QUALIFICATIONS
(Education/Experience/Knowledge, Skills & Abilities) - Bachelor\'s
Degree or equivalent, or 3-5 years\' related experience and/or training,
or equivalent combination of education and experience in quality
engineering in the medical industry - Knowledge of regulatory
requirements and industry standards (e.g., FDA QSR, ISO 13485). - Strong
understanding of quality management systems, material inspection
techniques, and root cause analysis methodologies. - Knowledge of GD&T
print interpretation, CAD Models, Statistical technique and Software,
Programming CMM\'s, Validation Activities (IQ, OQ, PQ), Cleanroom
practices, Sampling Technique. - Proficiency in data analysis and
problem-solving tools (e.g., 8D, FMEA, Pareto analysis). - Experience
leading or participating in CAPA investigations and resolution
activities. - Proficiency in problem-solving tools and techniques (e.g.,
5 Whys, Fishbone diagram, DMAIC). - Above average math skills (sound
knowledge in both statistics and calculus) - Ability to work with a high
volume of documents in a fast-paced environment - Experience with
programming and operation of Coordinate Measuring Machines (CMM),
inspection of machine components, and performance of gage R&R studies
preferred - Strong written, verbal, time management and interpersonal
skills - Ability to communicate effectively with all levels of staff and
management, both internal and external - Collaborate with
cross-functional teams - Leadership skills and team player - Highly
organized - Must have a strong attention to details - Strong Computer
skills; Microsoft Office (Word, Excel) and Minitab - Must be able to
lift up to 25 lbs. - Must be able to sit or stand for long periods of
time - Must be able to climb up and down stairs - Travel is required to
support company initiatives