Markem-Imaje · 2 months ago
Product Quality Engineer
Salem, NH
Full-time
Onsite
Senior Level
5+ years expMarkem-Imaje is a trusted world manufacturer of product identification and traceability solutions. The Product Quality Engineer will utilize Quality Engineering tools and practices to maintain and improve products/processes throughout the product lifecycle, ensuring compliance with relevant standards and regulations.
HardwareIndustrial AutomationLaserMachinery ManufacturingPrinting
Responsibilities
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements
Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs
Conduct benchmarking to develop more effective methods for improving quality
Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management for assigned value stream
Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the ISO/TS/ASTM/FDA/EU machine directive etc
Champions compliance to applicable Global Regulations and standards, and provide support during internal and external audits
Supports new product introduction as part of design transfer
Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate
Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Approve IQ, OQ, PQ, TMV or Software Validation for existing products
Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed
Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in product control plans
Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
Support Development of control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support
Develop, interpret and implement standard and non-standard sampling plans
Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis
Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data
Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits
Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
Ensures effective quality strategies are created for the validation of test methods, process and design
Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and can present data that facilitates/drives decision making is preferred
Conduct Quarterly Value Stream Product Line reviews
Qualification
Required
Bachelors Degree in Scientific or Engineering discipline
Minimum 5 years of quality engineering experience with a Bachelors degree. 7-10 years with an AS degree or 10-15 years of experience
Strong understanding of quality policies, ISO Standards
Strong knowledge of risk management
Strong knowledge in product/test method/process validations, and design controls
Strong knowledge in statistical process control and ability to apply advanced statistical techniques
Demonstrated use of Quality tools, principles and methodologies including lean and six sigma principles
Must be able to successfully work with all functional departments and all phases of company manufacturing and quality operations
4-8 years relevant experience with a focus on product quality and manufacturing quality
3-5 years as a Leader and facilitator of interdisciplinary project teams
Excellent communication and presentation skills
Statistical sampling and quality control methods
Design of experiments
CGMP's, QSR's, ISO, TS (auto), AS (Areospace), FDA (food and Drug) and TQMS quality systems
Risk Management and Hazard Analysis techniques
Data analysis
Quality by Design (QBD ICHQ10)
FMEA ASTM:J1739
IQ, OQ,PQ and PV plans
Excellent written and verbal communication, presentation and interpersonal skills
Ability to effectively manage multiple priorities and projects
Preferred
Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and can present data that facilitates/drives decision making is preferred
Six Sigma Green or Black Belt preferred
Benefits
401(k) savings plan with employer contributions
Medical, dental and vision insurance
Wellness programs
Health savings account
Health care and dependent care flexible spending accounts
Company paid short-term disability and long-term disability
Company paid employee basic life and AD&D insurance
Supplemental employee and dependent life insurance
Optional accident, hospital indemnity and critical illness insurance
Adoption, surrogacy, and fertility benefits and assistance
Commuter benefits
Parental, military, jury duty, and bereavement leaves of absence
Paid time off, including 10 paid holidays per calendar year
Paid vacation days beginning at 80 hours annually
64 paid sick leave hours annually or as provided under state and local paid sick leave laws
Tuition reimbursement at the maximum amount of $5,250 per employee per calendar year
Business travel services
Employee discounts
Employee assistance program that includes company paid counseling sessions and legal services
Company
Markem-Imaje
Markem-Imaje provides product identification and traceability solutions.
1001-5000 employees
H1B Sponsorship
Markem-Imaje has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (8)
2023 (4)
2022 (3)
2021 (10)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknown2006-12-06Acquired
Leadership Team
Vincent Vanderpoel
President and CEO
C
Christian Salanon
Chief Technology Officer
Recent News
EIN Presswire
2025-11-08
Company data provided by crunchbase