Senior Quality Engineer

Overview: Responsibilities:

• Establish and maintain strong relationships with key suppliers, leading audits, corrective actions and assessments to ensure compliance with quality standards
• Review and approve supplier corrective action plans and verification of effectiveness documentation
• Monitor supplier performance and supports efforts to develop and implement changes to improve the production process.Coordinate the evaluation of proposed changes at suppliers
• Plan and lead audits of suppliers to assess compliance with regulatory and Tactile Medical requirements, including audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions
• Collaborate with Manufacturing, Supply Chain, and Engineering as needed to address supplier quality issues
• Lead root cause investigations associated for quality issues and develop associated corrective action plans
• Participate in the non-conformance reporting system, driving timely disposition and closure. Participate in MRB meetings.
• Maintains risk management files for commercial products via periodic review of risk documents, complaints and nonconformance trends
• Supports DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Implement and oversee robust quality assurance processes for incoming materials, components and finished goods
• Track and report quality metrics
• Utilize statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities and develop statistically sound tolerance limits
• Identifies and leads continuous improvement projects
• Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Qualifications:

• Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science
• 5+ years of experience as a Quality Engineer within the medical device industry
• Ability to travel up to 15%

Preferred:

• Certified Quality Engineer (CQE)
• Certified Quality Auditor (CQA)
• Six Sigma Belt

• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
• Demonstrated skills in statistical analysis
• Strong analytical and problem-solving skills
• Ability to work in a fast paced, dynamic and growth environment
• Excellent interpersonal skills: ability to articulate verbally and written, review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and lead or conduct teams and meetings
• Proven ability to work with minimal direction, as well as be resourceful and independent in solving problems and multi-task effectively
• Strong attention to detail
• Ability to educate cross functional peers, stakeholders, suppliers and management on quality requirements
• Experienced with leading audits

Below is the starting salary range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.: $91,800 - $128,520 Additional benefits:: Exempt - Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.