Jobs · Quality Assurance · Massachusetts

Quality Manager / Safety Manager

Aitken Pharmacy · Westminster, MA · 2 mo ago
On-siteQuality AssuranceFull-time

Key Responsibilities

  • Oversee all aspects of quality control and assurance for injection molding operations.
  • Ensure products meet MILSPEC, UL, and ISO 9001:2015 requirements.
  • Own and maintain the Quality Management System (QMS), including procedures, work instructions, audits, and documentation.
  • Plan and lead internal and external audits, including customer, ISO, and regulatory audits.
  • Perform handson testing, inspections, and inprocess checks to ensure quality standards are maintained.
  • Review and approve quality plans, FMEAs, PPAPs, and control plans.
  • Drive root cause analysis, corrective/preventive action (CAPA), and nonconformance resolution.
  • Track and analyze Key Performance Indicators (KPIs); diagnose substandard metrics and identify predictive trends.
  • Manage and record changes to QMS forms and procedures; ensure documentation retention.
  • Serve as the primary point of contact for ISO audits and certification processes.
  • Investigate product non‐conformances, including material analysis and issuing Corrective Action Requests (CARs).
  • Oversee new product setup in Macola ERP, including product definition, BoM, and routing.
  • Cover Product Change Requests with affected departments and oversee updates to BoMs, work orders, etc.
  • Conduct Documented Internal Audits and Layered Process Audits across departments in preparation for ISO audits.
  • Train all new employees on quality assurance programs and initiatives.
  • Communicate the Quality Policy across the organization and verify understanding.
  • Issue retraining notices, when necessary, based on audit findings or customer complaints.
  • Investigate customer complaints in collaboration with relevant departments.
  • Serve as the primary liaison for customer quality inquiries and audits.
  • Work directly with Sales, Manufacturing, Engineering, and Procurement to address customer requirements and quality expectations.
  • Support product development and launch activities by providing quality input and validation.
  • Serve as a liaison for quality concerns between the company and customers/suppliers.

Qualifications

  • 57 years of quality experience in injection molding or plastics manufacturing.
  • Minimum 3 years in a leadership or managerial role in a manufacturing environment.
  • Proven experience with ISO 9001:2015, MILSPEC, and UL standards.
  • Strong knowledge of quality tools and methodologies: SPC, APQP, CAPA, FMEA, MSA, PPAP, GD&T.
  • Handson experience with metrology tools (e.g., calipers, micrometers, CMM, gauges).
  • Proficient in Microsoft Office Suite and QMS software.
  • Strong analytical, organizational, and interpersonal skills.
  • Excellent verbal and written communication skills.
  • Ability to thrive in a handson, fastpaced, and teamoriented environment.
  • Team‐oriented with a commitment to company goals.
  • Willingness to maintain a clean and safe work environment.
  • Adherence to company attendance policy.
  • ISO 9001:2015 Lead Auditor certification.
  • Preferred Education / Experience:
    • Associate's or bachelor’s degree in Engineering, Quality, or related technical field.
    • Certifications in Lean, Six Sigma, or Quality Engineering (CQE).
    • Familiarity with metallurgy or tool manufacturing.

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