We are looking for a Sr. Quality Engineer with expertise in Sustained Manufacturing. This position will be responsible for the activities associated with Quality Sustained Manufacturing of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

ESSENTIAL FUNCTIONS:

• Initiate and/or consult in the development and/or update of Risk Management FMEA documentation in cooperation with cross-functional engineering teams per project requirements
• Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams
• Provide direction in implementing and continuously improving Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans
• Ensure the continuous efficiency and improvement of Test/Inspection Methods
• Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria
• Apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPAs, Complaints and NCRs
• Provide statistical data / trending analysis on Complaints, NCRs and other quality metrics to drive escalation and appropriate Corrective Actions to mitigate future recurrences of nonconformances
• Conduct audits for internal manufacturing processes to ensure compliance with work instructions, summarize findings, outline opportunities for improvement, and proactively identify potential non-conformances
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments
• Provide support for the compliance of Quality System support elements (QM 'feeder' systems) for the site QMS and the tracking & reporting of associated metrics as required
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts
• Support site customer-requested auditing activities (Customer and Regulatory Agencies)
• Ensure compliance of all site personnel to site-level QMS and functional training requirements
• May support the improvement of Quality Agreements for external customers.

QUALIFICATIONS:

• Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred)
• Minimum of 4-6 years’ experience in a regulated manufacturing environment
• Advanced Post-Secondary Education/Training/Certification coursework
• Quality certification(s) (e.g. ASQ CQE, QCI, etc.)
• Class I, II and/or III Medical Device manufacturing experience
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints)
• Experience in effectively supporting audits by customers and external regulatory agencies
• Strong verbal and written English language communication skills.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint)
• “Hands-on” self-starter with ability to work both independently and as part of a team
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA

Job Types: Full-time, Contract

Pay: Up to $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Knightstown, IN 46148: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001: 1 year (Preferred)

License/Certification:

• ASQ Certification (Preferred)
• Certified Quality Engineer Certification (Preferred)

Work Location: One location

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