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.